xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05966337</url>
    </required_header>
    <id_info>
      <org_study_id>ERAECR12023</org_study_id>
      <secondary_id>65600722.1.0000.5187</secondary_id>
      <nct_id>NCT05966337</nct_id>
    </id_info>
    <brief_title>Effects of Non-invasive Ventilation in Patients Undergoing Heart Surgery</brief_title>
    <official_title>Effects of Non-invasive Ventilation With Different Modalities in Patients Undergoing Heart Surgery: a Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidade Federal do Rio Grande do Norte</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Universidade Estadual da Paraiba</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universidade Federal do Rio Grande do Norte</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized controlled clinical trial is to compare effects of non-invasive&#xD;
        ventilation with different modalities (notably CPAP and BIPAP) in patients undergoing heart&#xD;
        surgery. The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Which NIV ventilation mode is most effective in cardiac surgery patients?&#xD;
  &#xD;
          -  Is there a big difference between conventional physiotherapy treatment and the use of&#xD;
             NIV in these patients? Participants will be submited in the intervention will initially&#xD;
             take place in the specific ward that receives patients in the postoperative period of&#xD;
             cardiac surgery. Participants will be recruited after the patient is hospitalized the&#xD;
             day before the surgery, during which time he will undergo a preoperative evaluation&#xD;
             based on the study criteria. On that first day, the evaluation will consist of anamnesis&#xD;
             and physical examination, focusing on the history of cardiac disorders, followed by&#xD;
             measurements inherent to the protocol. Manovacuometry, chest X-ray, quality of life&#xD;
             questionnaire, walk test and spirometry. The evaluation can be carried out in two&#xD;
             stages, if there are other demands for the patient during his hospitalization.&#xD;
  &#xD;
        Researchers will compare three groups: 1 - cpap group - CPAP + usual physical therapy care, 2&#xD;
        - Bipap group - BIPAP + usual physical therapy care and 3 - Control - usual physical therapy&#xD;
        care), in the 1:1 allocation ratio and superiority. to see if the effects of non-invasive&#xD;
        ventilation with different modalities in patients undergoing cardiac surgery demonstrates&#xD;
        some superior way in clinical practice. The observed outcomes will be: evaluation between NIV&#xD;
        modalities, spirometry, lung capacity and vital signs. Secondary outcomes included are degree&#xD;
        of satisfaction with the global perception of change scale, and MIF - functional independence&#xD;
        measure and blood gas parameters.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study protocol was conducted following the Standard Protocol Items: Recommendations for&#xD;
        Interventional Trials (SPIRIT) checklist. This is a single-center, randomized, controlled,&#xD;
        double-blind clinical trial, in which participants and outcome evaluators were blinded. The&#xD;
        study will be submitted to the ethics committee of the State University of Paraíba (UEPB) and&#xD;
        carried out in accordance with the Declaration of Helsinki. All participants must provide&#xD;
        written informed consent prior to participation, and the study will be registered on the&#xD;
        CLINICALTRIALS platform. All participants must provide written informed consent prior to&#xD;
        participation. Participants will be divided into three groups (cpap group - CPAP + usual&#xD;
        physical therapy care, bipap group - BIPAP + usual physical therapy care and control group -&#xD;
        usual physical therapy care), in a 1:1 allocation ratio and superiority.&#xD;
  &#xD;
        The project will be carried out at Hospital João XXIII in the city of Campina Grande,&#xD;
        Paraíba, Brazil. It is a private hospital affiliated with the SUS network, a reference in&#xD;
        cardiology and especially in cardiac surgery for a good part of the state and surrounding&#xD;
        states. It presents in its weekly program an average of 8 cardiac surgeries. The evaluation&#xD;
        and intervention will take place in the ICU and ward.&#xD;
  &#xD;
        Post-randomization exclusion criteria: In case of undertaking any treatment in the hospital&#xD;
        environment that contraindicates participation in the study (pacemaker implantation,&#xD;
        pneumothorax requiring chest drainage, for example), death or other decompensations not&#xD;
        related to the research and return to the ICU .&#xD;
  &#xD;
        Criteria for non-adherence to the intervention: Patient who does not perform 3 or more&#xD;
        sessions in a row, who withdrew from participating in the study and who has some cardiac&#xD;
        arrhythmia (atrial fibrillation, bradycardia) for two sessions even after medication used to&#xD;
        contain and pause for rest.&#xD;
  &#xD;
        Non-retention criteria: Patient who does not perform one of the reassessments. Professional&#xD;
        eligibility criteria: Hospital staff physiotherapists and physiotherapy students with&#xD;
        previous training in the research protocol.&#xD;
  &#xD;
        Procedures for Conducting the Research The purpose of this project is to carry out a&#xD;
        randomized clinical trial and verify the effectiveness of NIV compared to conventional&#xD;
        physiotherapy in terms of the rate of pulmonary complications in patients undergoing cardiac&#xD;
        surgery in a chosen hospital in the city of Campina Grande, Paraíba.&#xD;
  &#xD;
        Thus, there will be a partnership with the Núcleo de Tecnologia Estratégicas em Saúde (NUTES)&#xD;
        of the State University of Paraíba (UEPB) through the biomedical computing laboratory for the&#xD;
        development of research aimed at the remote monitoring of health data through smartwatches&#xD;
        and other devices that comply with international standardization norms for interoperability&#xD;
        between health technologies. NUTES already collaborates with UFRN in several scientific and&#xD;
        technological cooperation researches, so that the co-supervisor of the project, Prof Paulo&#xD;
        Eduardo Barbosa made the strategic partnership possible, according to the attached document.&#xD;
        NUTES' participation in this project will take place through the feasibility of remote&#xD;
        monitoring technology via Smartwatch and the introduction of data collected on a specific&#xD;
        platform.&#xD;
  &#xD;
        For a better understanding and operationalization of the research, it was divided into 5&#xD;
        phases.&#xD;
  &#xD;
          1. st Phase: Documentary Survey and Consent At first, there was initial contact with the&#xD;
             aforementioned hospital institution for consent to the research. At the same time, a&#xD;
             documentary and systematic study on the subject was instituted, in order to base the&#xD;
             research and identify possible indices and/or parameters that would add to the research&#xD;
             in order to make it viable and absolutely realistic.&#xD;
  &#xD;
          2. nd Phase: Search and profile of NIV and Smartwatch devices Non-invasive ventilation&#xD;
             (NIV) will be performed both in the ICU environment and in the ward for the intervention&#xD;
             group. A BIPAP will be made available and a CPAP for the respective groups. The&#xD;
             interface chosen will be the nasal mask, aiming at greater patient comfort. Thus, we&#xD;
             will choose properly calibrated NIV devices on the market that provide better adaptation&#xD;
             to patients.&#xD;
  &#xD;
             All the main information about users can be entered into the platform, such as gender,&#xD;
             age, other illnesses, use of medication, and some special situations that can be&#xD;
             verified in practice, in addition to information that may come from the monitoring&#xD;
             carried out by the smartwatch on patients in the moment of data collection during NIV&#xD;
             application. Thus, data from the patient's medical record will also be used. A large&#xD;
             volume of data can be entered into the platform and used to generate a profile of&#xD;
             cardiac patients selected for the survey. The smartwatch used will be from the Garmin&#xD;
             brand and available for capturing Sao2 and VO2.&#xD;
  &#xD;
             The main functionalities of the Dashboard comprise the visualization of the data of the&#xD;
             surgical patients submitted to NIV in the initial screen in a computer, being able to&#xD;
             apply filters according to the interest of the researcher.&#xD;
  &#xD;
          3. rd Phase: Technical Study and applied tests&#xD;
  &#xD;
             This project is interested in three major aspects: the use of non-invasive ventilation&#xD;
             in heart patients undergoing cardiac surgery; the automation of data collection using&#xD;
             the smartwatch, making it practical, simple, accessible technology in order to become a&#xD;
             predictor of safe discharge for these patients; finally, a survey of a large volume of&#xD;
             data (verified in the analysis profile of the patients) that can generate subsidies for&#xD;
             carrying out research and contribute to the increase of studies in the area of&#xD;
             cardiopulmonary physiotherapy on technological bases.&#xD;
  &#xD;
          4. th Phase: Pilot Study - Practice After that, the surgeries will begin and the collection&#xD;
             will consist of 6 patients, thus defining the beginning of the pilot study. Upon being&#xD;
             notified of the weekly surgical schedule, the researcher in charge will randomize the&#xD;
             patients. This register will contain the complete identification of the patient, type of&#xD;
             surgery to which he will be submitted and the pathology.&#xD;
  &#xD;
             Thus, as the patients leave the surgical center and go to the ICU, they will follow the&#xD;
             protocol so that the treatment due to the group to which the patient is allocated on the&#xD;
             day after the surgery begins.&#xD;
  &#xD;
             It should be noted that the pilot study should only be started after approval by CEP.&#xD;
  &#xD;
             After completion of the pilot study, there will be an evaluation of the entire protocol&#xD;
             so that possible flaws can be corrected before definitive collection.&#xD;
  &#xD;
          5. th Phase: Data collection It will consist of collecting data from patients in the&#xD;
             post-randomization intervention and allocation of patients to a group, following the&#xD;
             procedures of the protocol.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Pacients will be divided into 3 groups (CPAP group - CPAP + usual physical therapy care, BiPAP group - BiPAP + usual physical therapy care, and Control group - usual physical therapy care) in a 1:1 allocation ratio. Control group will receive the usual physiotherapy treatment, as kinesiotherapy protocol. Treatment will be administered twice a day, starting in the ICU and progressing to the ward. In the CPAP group, nasal CPAP at 10cmH2O will be administered for 1 hour, twice a day, using an approved device. In BiPAP group, nasal BiPAP with IPAP of 13cmH2O and EPAP of 8cmH2O will be administered for 1 hour, twice a day, using an approved device. The NIV sessions will be conducted during the 5 days of hospitalization, both in the ICU and the ward. After the fifth day, patients in intervention groups will undergo reassessment using the same assessment instruments as before.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>This is a single-center, randomized, controlled, double-blind clinical trial, in which participants and outcome evaluators were blinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pulmonary function</measure>
      <time_frame>Day 1 and day 5</time_frame>
      <description>All participants will undergo an evaluation by a CONTEC model spirometer (SPB80b, CHINA) to verify lung volumes and capacities. At least three tests will be performed, with a variation of less than 5% and the highest value obtained in one of the tests will be compared with the predicted values of pulmonary function parameters for the Brazilian population. FEV1 and FVC will be assessed. The predicted values will be calculated using the reference values (PEREIRA et al., 2007).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>The length of hospital stay will be assessed and reported as the number of days from admission to discharge, measured up to 2 weeks after the date of randomization.</time_frame>
      <description>Absolute number of days of hospitalization up to 2 weeks after the date of randomization.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Presence of lung complications</measure>
      <time_frame>From the date of randomization to the date of the first documented progression or the date of death from any cause, whichever occurs first, measured up to 2 weeks after the date of hospital discharge.</time_frame>
      <description>assessment of the occurrence or absence of any complications related to the lungs during the hospitalization period.cause, whichever occurs first, measured up to 2 weeks</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Score of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) in Portuguese version</measure>
      <time_frame>Day 1 and Day 5</time_frame>
      <description>The Portuguese version of the MLHFQ will be used to assess the patient's quality of life. The questionnaire provides a final score as a metric, and the change in score over the treatment period will be evaluated. The MLHFQ score is a measure of health-related quality of life in patients with heart failure. The higher the score, the greater the negative impact of heart failure on the patient's quality of life. A score of 0 indicates that the patient has no limitations or problems related to heart failure, while a score of 105 indicates a maximum limitation or problem in all areas assessed by the questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Funcional capacity</measure>
      <time_frame>Day 1 and Day 5</time_frame>
      <description>The TUG test will be performed to assess functional capacity. The patient will start from a sitting position, walk quickly for 3 meters, turn 180 degrees, and return to the chair. The time taken, measured from standing up to completely leaning the trunk against the chair, will be recorded. Time values below 10 seconds indicate maximum functionality, 10 to 19 seconds indicate functional independence, 20 seconds and above indicate some functional limitation, and 30 seconds and above indicate significant functional limitation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The global perception of change scale</measure>
      <time_frame>Day 1 and Day 5</time_frame>
      <description>The GPCS is a self-report tool that assesses an individual's perception of change in a specific domain. It uses Likert-scale items ranging from &quot;a very great deal worse/less&quot; to &quot;a very great deal better/more&quot; to capture subjective information about perceived change.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The functional independence measure (MIF)</measure>
      <time_frame>Day 1 and Day 5</time_frame>
      <description>The MIF questionnaire will be administered preoperatively and on the sixth day to assess functional independence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pO2 (partial pressure of oxygen)</measure>
      <time_frame>Days 1 and 2.</time_frame>
      <description>Partial pressure of oxygen (PO2) is a key physiological parameter that measures the pressure exerted solely by oxygen molecules in a mixture of gases, such as air or blood. It is an important indicator of the oxygen-carrying capacity and oxygen exchange efficiency in the respiratory system (ROCA et al. 2020). PO2 will be measured in millimeters of mercury (mmHg) (BAI, et al. 2020)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pCO2 (partial pressure of carbon dioxide)</measure>
      <time_frame>Days 1 and 2.</time_frame>
      <description>Partial pressure of carbon dioxide (pCO2) is a fundamental physiological parameter that measures the pressure exerted solely by carbon dioxide molecules in a mixture of gases, such as air or blood. It plays a crucial role in the regulation of acid-base balance and respiratory function.&#xD;
  The unit of measurement for pCO2 will be expressed in millimeters of mercury (mmHg).(RODRIGUEZ, 2006)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HCO3 (bicarbonate)</measure>
      <time_frame>Days 1 and 2.</time_frame>
      <description>Bicarbonate (HCO3) is an important physiological parameter that measures the concentration of bicarbonate ions in the blood. It is a vital component of the body's acid-base balance and plays a crucial role in maintaining the pH of the blood within a normal range.&#xD;
  The unit of measurement for bicarbonate will be expressed in milliequivalents per liter (mEq/L) (CHUA, 2011).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arterial Oxygen Saturation (SaO2)</measure>
      <time_frame>Days 1 and 2.</time_frame>
      <description>Arterial Oxygen Saturation (SaO2) is a critical physiological parameter that measures the percentage of hemoglobin in arterial blood that is bound with oxygen. It reflects the efficiency of oxygen transport from the lungs to the body's tissues.&#xD;
  The unit of measurement for SaO2 is typically expressed as a percentage (%). (CASTRO, et al, 2022)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Base Excess (BE)</measure>
      <time_frame>Days 1 and 2.</time_frame>
      <description>Base Excess (BE) is a significant physiological parameter that measures the amount of excess or deficit of base (bicarbonate) in the blood, indicating the body's acid-base balance. It quantifies the deviation of the blood's buffering capacity from the normal range, which helps in assessing the metabolic component of acid-base disturbances.&#xD;
  The unit of measurement for Base Excess will be expressed in milliequivalents per liter (mEq/L) (CASTRO, et al, 2022)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Duration of Cardiopulmonary Bypass</measure>
      <time_frame>Day 1</time_frame>
      <description>The duration of cardiopulmonary bypass during the cardiac surgery. • Unit of Measure: minutes</description>
    </other_outcome>
    <other_outcome>
      <measure>Type of Surgery</measure>
      <time_frame>Day 1</time_frame>
      <description>The specific type of cardiac surgery performed. • Unit of Measure: N/A (Categorical Variable)</description>
    </other_outcome>
    <other_outcome>
      <measure>Personal History</measure>
      <time_frame>Day 1</time_frame>
      <description>Relevant information about the patient's personal medical history. • Unit of Measure: N/A (Categorical Variable)</description>
    </other_outcome>
    <other_outcome>
      <measure>Preoperative Ejection Fraction</measure>
      <time_frame>Day 1</time_frame>
      <description>The percentage of preoperative cardiac ejection fraction.• Unit of Measure: percentage (%)</description>
    </other_outcome>
    <other_outcome>
      <measure>Previous Respiratory Complications</measure>
      <time_frame>Day 1</time_frame>
      <description>Indication of the presence or absence of previous respiratory complications. • Unit of Measure: N/A (Categorical Variable)</description>
    </other_outcome>
    <other_outcome>
      <measure>Body Mass Index (BMI)</measure>
      <time_frame>Day 1</time_frame>
      <description>The patient's body mass index, calculated as weight (in kg) divided by the square of height (in meters). Unit of Measure: N/A (Calculated from weight and height)</description>
    </other_outcome>
    <other_outcome>
      <measure>Gender</measure>
      <time_frame>Day 1</time_frame>
      <description>The patient's gender (male or female). Unit of Measure: N/A (Categorical Variable)</description>
    </other_outcome>
    <other_outcome>
      <measure>Age</measure>
      <time_frame>Day 1</time_frame>
      <description>The patient's age in years</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">62</enrollment>
    <condition>Cardiac Surgical Procedures</condition>
    <condition>Continuous Positive Airway Pressure</condition>
    <condition>BIPAP Biphasic Intermittent Positive Airway Pressure</condition>
    <arm_group>
      <arm_group_label>Control group 1 (usual care)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients undergo physiotherapy treatment twice daily, transitioning from the ICU to the ward. The treatment plan spans several days, starting on the first postoperative day after ICU discharge. In the ICU, Day 1 includes diaphragmatic breathing exercises, coughing stimulus, upper limb exercises (shoulder flexion/extension, abduction), and lower limb exercises (thigh flexion, dorsiflexion/plantarflexion). Day 2 involves diaphragmatic breathing, coughing stimulus, upper limb exercises, lower limb exercises, cycling for 3 minutes, and respiratory device exercises. Upon moving to the ward on Day 3, patients perform diaphragmatic breathing, coughing stimulus, upper limb exercises, lower limb exercises, and a 5-minute walk. Day 4 focuses on diaphragmatic breathing, coughing stimulus, and a 10-minute walk. Finally, on Day 5, patients engage in diaphragmatic breathing, coughing stimulus, and a 15-minute walk.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention group 2 (CPAP)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>They will be submitted to the same care as the control group, adding NIV with nasal CPAP 10cmH2O for 1 hour using device and brand approved by ANVISA, during the 5 days of hospitalization, both in the ICU and in the ward. The frequency of the sessions will be two (2) per day, in the morning and in the afternoon. Flexibility of time for carrying out the procedure is also planned, since in a hospital environment the patient can often undergo exams, other behaviors that may make it difficult to apply the protocol at the initially scheduled time. After the fifth day, the patient will be reassessed with the same instruments reported.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention group 2 (BIPAP):</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>They will undergo the same care as the control group, adding NIV with nasal BIPAP with IPAP of 13cmH2O and EPAP 8 cmH2O for 1 hour, using equipment and brand approved by ANVISA, during the 5 days of hospitalization, both in the ICU and in the ward . The frequency of the sessions will be two (2) per day, in the morning and in the afternoon. Flexibility of time for carrying out the procedure is also planned, since in a hospital environment the patient can often undergo exams, other behaviors that may make it difficult to apply the protocol at the initially scheduled time. After the fifth day, the patient will be reassessed with the same instruments reported.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>CPAP</intervention_name>
      <description>Use of non-invasive ventilation in patients in group 2 with CPAP.</description>
      <arm_group_label>Intervention group 2 (CPAP)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>BIPAP</intervention_name>
      <description>Use of non-invasive ventilation in patients in group 3 with BIPAP.</description>
      <arm_group_label>Intervention group 2 (BIPAP):</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Usual care in phisicaltherapy</intervention_name>
      <description>Patients undergoing usual physiotherapy treatment, consisting of a kinesiotherapy protocol</description>
      <arm_group_label>Control group 1 (usual care)</arm_group_label>
      <arm_group_label>Intervention group 2 (BIPAP):</arm_group_label>
      <arm_group_label>Intervention group 2 (CPAP)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: Patients undergoing cardiac surgery&#xD;
  &#xD;
            -  aged over 18 years&#xD;
  &#xD;
            -  stable from the hemodynamic point of view (controlled blood pressure, normocardic&#xD;
  &#xD;
            -  conscious and oriented and cooperative4&#xD;
  &#xD;
            -  without medical restrictions for carrying out the treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of uncontrolled cardiac arrhythmias (Examples: total atrioventricular block,&#xD;
               type 2 2nd degree atrioventricular block, atrial fibrillation, sustained ventricular&#xD;
               tachycardia)&#xD;
  &#xD;
            -  previous neuromuscular disease&#xD;
  &#xD;
            -  labyrinthitis and some orthopedic/skeletal muscle restriction.&#xD;
  &#xD;
            -  Unstable angina, stage 3 SAH (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at rest), HR &gt; 120&#xD;
               bpm at rest, systemic arterial hypotension with clinical repercussions (SBP ≤ 90 mmHg&#xD;
               and/or DBP ≤ 60 mmHg),(),&#xD;
  &#xD;
            -  aortic dissection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Eder R Araújo, doctoral</last_name>
      <phone>+5583988998813</phone>
      <email>eder.rodrigues.araujo@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Patrícia Nogueira, doctor</last_name>
      <phone>+5584988777454</phone>
      <email>idpa02@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital João XXIII</name>
        <address>
          <city>Campina Grande</city>
          <state>PB</state>
          <zip>58108-620</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eder R Araújo, doctoral</last_name>
        <phone>83988998813</phone>
        <email>eder.rodrigues.araujo@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <reference>
      <citation>Hossen A, Jaju D, Al-Abri M, Al-Sabti H, Mukaddirov M, Hassan M, Al-Hashmi K. Investigation of heart rate variability of patients undergoing coronary artery bypass grafting (CABG). Technol Health Care. 2017;25(2):197-210. doi: 10.3233/THC-161260.</citation>
      <PMID>28387685</PMID>
    </reference>
    <reference>
      <citation>Du H, Newton PJ, Salamonson Y, Carrieri-Kohlman VL, Davidson PM. A review of the six-minute walk test: its implication as a self-administered assessment tool. Eur J Cardiovasc Nurs. 2009 Mar;8(1):2-8. doi: 10.1016/j.ejcnurse.2008.07.001. Epub 2008 Aug 9.</citation>
      <PMID>18694656</PMID>
    </reference>
    <reference>
      <citation>Shakouri SK, Salekzamani Y, Taghizadieh A, Sabbagh-Jadid H, Soleymani J, Sahebi L, Sahebi R. Effect of respiratory rehabilitation before open cardiac surgery on respiratory function: a randomized clinical trial. J Cardiovasc Thorac Res. 2015;7(1):13-7. doi: 10.15171/jcvtr.2015.03. Epub 2015 Mar 29.</citation>
      <PMID>25859310</PMID>
    </reference>
    <reference>
      <citation>Valkenet K, de Heer F, Backx FJ, Trappenburg JC, Hulzebos EH, Kwant S, van Herwerden LA, van de Port IG. Effect of inspiratory muscle training before cardiac surgery in routine care. Phys Ther. 2013 May;93(5):611-9. doi: 10.2522/ptj.20110475. Epub 2013 Jan 3.</citation>
      <PMID>23288909</PMID>
    </reference>
    <reference>
      <citation>Dos Santos TD, Pereira SN, Portela LOC, Cardoso DM, Lago PD, Dos Santos Guarda N, Moresco RN, Pereira MB, de Albuquerque IM. Moderate-to-high intensity inspiratory muscle training improves the effects of combined training on exercise capacity in patients after coronary artery bypass graft surgery: A randomized clinical trial. Int J Cardiol. 2019 Mar 15;279:40-46. doi: 10.1016/j.ijcard.2018.12.013. Epub 2018 Dec 10.</citation>
      <PMID>30581100</PMID>
    </reference>
    <reference>
      <citation>American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.</citation>
      <PMID>12186831</PMID>
    </reference>
    <reference>
      <citation>Carvalho VO, Guimaraes GV, Carrara D, Bacal F, Bocchi EA. Validation of the Portuguese version of the Minnesota Living with Heart Failure Questionnaire. Arq Bras Cardiol. 2009 Jul;93(1):39-44. doi: 10.1590/s0066-782x2009000700008. English, Portuguese, Spanish.</citation>
      <PMID>19838469</PMID>
    </reference>
    <reference>
      <citation>8. Vieira WO, Barbosa LK, Bezerra AS, et al. Test timed up and go and its correlation with age and functional exercise capacity in asymptomatic women. Fisioterapia em Movimento. 2017;30(3):463-471. doi:10.1590/1980-5918.030.003.AO04.</citation>
    </reference>
    <reference>
      <citation>Bretan O, Silva Junior JE, Ribeiro OR, Corrente JE. Risk of falling among elderly persons living in the community: assessment by the Timed up and go test. Braz J Otorhinolaryngol. 2013 Jan-Feb;79(1):18-21. doi: 10.5935/1808-8694.20130004.</citation>
      <PMID>23503902</PMID>
    </reference>
    <reference>
      <citation>Behlouli H, Feldman DE, Ducharme A, Frenette M, Giannetti N, Grondin F, Michel C, Sheppard R, Pilote L. Identifying relative cut-off scores with neural networks for interpretation of the Minnesota Living with Heart Failure questionnaire. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6242-6. doi: 10.1109/IEMBS.2009.5334659.</citation>
      <PMID>19965089</PMID>
    </reference>
    <reference>
      <citation>Bai C, Chotirmall SH, Rello J, Alba GA, Ginns LC, Krishnan JA, Rogers R, Bendstrup E, Burgel PR, Chalmers JD, Chua A, Crothers KA, Duggal A, Kim YW, Laffey JG, Luna CM, Niederman MS, Raghu G, Ramirez JA, Riera J, Roca O, Tamae-Kakazu M, Torres A, Watkins RR, Barrecheguren M, Belliato M, Chami HA, Chen R, Cortes-Puentes GA, Delacruz C, Hayes MM, Heunks LMA, Holets SR, Hough CL, Jagpal S, Jeon K, Johkoh T, Lee MM, Liebler J, McElvaney GN, Moskowitz A, Oeckler RA, Ojanguren I, O'Regan A, Pletz MW, Rhee CK, Schultz MJ, Storti E, Strange C, Thomson CC, Torriani FJ, Wang X, Wuyts W, Xu T, Yang D, Zhang Z, Wilson KC. Updated guidance on the management of COVID-19: from an American Thoracic Society/European Respiratory Society coordinated International Task Force (29 July 2020). Eur Respir Rev. 2020 Oct 5;29(157):200287. doi: 10.1183/16000617.0287-2020. Print 2020 Sep 30.</citation>
      <PMID>33020069</PMID>
    </reference>
    <reference>
      <citation>Rodriguez P, Lellouche F, Aboab J, Buisson CB, Brochard L. Transcutaneous arterial carbon dioxide pressure monitoring in critically ill adult patients. Intensive Care Med. 2006 Feb;32(2):309-312. doi: 10.1007/s00134-005-0006-4. Epub 2006 Jan 31.</citation>
      <PMID>16450093</PMID>
    </reference>
    <reference>
      <citation>Chua HR, Schneider A, Bellomo R. Bicarbonate in diabetic ketoacidosis - a systematic review. Ann Intensive Care. 2011 Jul 6;1(1):23. doi: 10.1186/2110-5820-1-23.</citation>
      <PMID>21906367</PMID>
    </reference>
    <reference>
      <citation>Castro D, Patil SM, Keenaghan M. Arterial Blood Gas. 2022 Sep 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536919/</citation>
      <PMID>30725604</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 8, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidade Federal do Rio Grande do Norte</investigator_affiliation>
      <investigator_full_name>Patri-cia Angelica de Miranda Silva Nogueira</investigator_full_name>
      <investigator_title>Head professor of physiotherapy course and pós-graduate course.</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05966337
  org study id: ERAECR12023
  secondary id: 65600722.1.0000.5187
  nct id: NCT05966337
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled clinical trial is to compare effects of non-invasive
        ventilation with different modalities (notably CPAP and BIPAP) in patients undergoing heart
        surgery. The main question[s] it aims to answer are:
  
          -  Which NIV ventilation mode is most effective in cardiac surgery patients?
  
          -  Is there a big difference between conventional physiotherapy treatment and the use of
             NIV in these patients? Participants will be submited in the intervention will initially
             take place in the specific ward that receives patients in the postoperative period of
             cardiac surgery. Participants will be recruited after the patient is hospitalized the
             day before the surgery, during which time he will undergo a preoperative evaluation
             based on the study criteria. On that first day, the evaluation will consist of anamnesis
             and physical examination, focusing on the history of cardiac disorders, followed by
             measurements inherent to the protocol. Manovacuometry, chest X-ray, quality of life
             questionnaire, walk test and spirometry. The evaluation can be carried out in two
             stages, if there are other demands for the patient during his hospitalization.
  
        Researchers will compare three groups: 1 - cpap group - CPAP + usual physical therapy care, 2
        - Bipap group - BIPAP + usual physical therapy care and 3 - Control - usual physical therapy
        care), in the 1:1 allocation ratio and superiority. to see if the effects of non-invasive
        ventilation with different modalities in patients undergoing cardiac surgery demonstrates
        some superior way in clinical practice. The observed outcomes will be: evaluation between NIV
        modalities, spirometry, lung capacity and vital signs. Secondary outcomes included are degree
        of satisfaction with the global perception of change scale, and MIF - functional independence
        measure and blood gas parameters.
  The study protocol was conducted following the Standard Protocol Items: Recommendations for
        Interventional Trials (SPIRIT) checklist. This is a single-center, randomized, controlled,
        double-blind clinical trial, in which participants and outcome evaluators were blinded. The
        study will be submitted to the ethics committee of the State University of Paraíba (UEPB) and
        carried out in accordance with the Declaration of Helsinki. All participants must provide
        written informed consent prior to participation, and the study will be registered on the
        CLINICALTRIALS platform. All participants must provide written informed consent prior to
        participation. Participants will be divided into three groups (cpap group - CPAP + usual
        physical therapy care, bipap group - BIPAP + usual physical therapy care and control group -
        usual physical therapy care), in a 1:1 allocation ratio and superiority.
  
        The project will be carried out at Hospital João XXIII in the city of Campina Grande,
        Paraíba, Brazil. It is a private hospital affiliated with the SUS network, a reference in
        cardiology and especially in cardiac surgery for a good part of the state and surrounding
        states. It presents in its weekly program an average of 8 cardiac surgeries. The evaluation
        and intervention will take place in the ICU and ward.
  
        Post-randomization exclusion criteria: In case of undertaking any treatment in the hospital
        environment that contraindicates participation in the study (pacemaker implantation,
        pneumothorax requiring chest drainage, for example), death or other decompensations not
        related to the research and return to the ICU .
  
        Criteria for non-adherence to the intervention: Patient who does not perform 3 or more
        sessions in a row, who withdrew from participating in the study and who has some cardiac
        arrhythmia (atrial fibrillation, bradycardia) for two sessions even after medication used to
        contain and pause for rest.
  
        Non-retention criteria: Patient who does not perform one of the reassessments. Professional
        eligibility criteria: Hospital staff physiotherapists and physiotherapy students with
        previous training in the research protocol.
  
        Procedures for Conducting the Research The purpose of this project is to carry out a
        randomized clinical trial and verify the effectiveness of NIV compared to conventional
        physiotherapy in terms of the rate of pulmonary complications in patients undergoing cardiac
        surgery in a chosen hospital in the city of Campina Grande, Paraíba.
  
        Thus, there will be a partnership with the Núcleo de Tecnologia Estratégicas em Saúde (NUTES)
        of the State University of Paraíba (UEPB) through the biomedical computing laboratory for the
        development of research aimed at the remote monitoring of health data through smartwatches
        and other devices that comply with international standardization norms for interoperability
        between health technologies. NUTES already collaborates with UFRN in several scientific and
        technological cooperation researches, so that the co-supervisor of the project, Prof Paulo
        Eduardo Barbosa made the strategic partnership possible, according to the attached document.
        NUTES' participation in this project will take place through the feasibility of remote
        monitoring technology via Smartwatch and the introduction of data collected on a specific
        platform.
  
        For a better understanding and operationalization of the research, it was divided into 5
        phases.
  
          1. st Phase: Documentary Survey and Consent At first, there was initial contact with the
             aforementioned hospital institution for consent to the research. At the same time, a
             documentary and systematic study on the subject was instituted, in order to base the
             research and identify possible indices and/or parameters that would add to the research
             in order to make it viable and absolutely realistic.
  
          2. nd Phase: Search and profile of NIV and Smartwatch devices Non-invasive ventilation
             (NIV) will be performed both in the ICU environment and in the ward for the intervention
             group. A BIPAP will be made available and a CPAP for the respective groups. The
             interface chosen will be the nasal mask, aiming at greater patient comfort. Thus, we
             will choose properly calibrated NIV devices on the market that provide better adaptation
             to patients.
  
             All the main information about users can be entered into the platform, such as gender,
             age, other illnesses, use of medication, and some special situations that can be
             verified in practice, in addition to information that may come from the monitoring
             carried out by the smartwatch on patients in the moment of data collection during NIV
             application. Thus, data from the patient's medical record will also be used. A large
             volume of data can be entered into the platform and used to generate a profile of
             cardiac patients selected for the survey. The smartwatch used will be from the Garmin
             brand and available for capturing Sao2 and VO2.
  
             The main functionalities of the Dashboard comprise the visualization of the data of the
             surgical patients submitted to NIV in the initial screen in a computer, being able to
             apply filters according to the interest of the researcher.
  
          3. rd Phase: Technical Study and applied tests
  
             This project is interested in three major aspects: the use of non-invasive ventilation
             in heart patients undergoing cardiac surgery; the automation of data collection using
             the smartwatch, making it practical, simple, accessible technology in order to become a
             predictor of safe discharge for these patients; finally, a survey of a large volume of
             data (verified in the analysis profile of the patients) that can generate subsidies for
             carrying out research and contribute to the increase of studies in the area of
             cardiopulmonary physiotherapy on technological bases.
  
          4. th Phase: Pilot Study - Practice After that, the surgeries will begin and the collection
             will consist of 6 patients, thus defining the beginning of the pilot study. Upon being
             notified of the weekly surgical schedule, the researcher in charge will randomize the
             patients. This register will contain the complete identification of the patient, type of
             surgery to which he will be submitted and the pathology.
  
             Thus, as the patients leave the surgical center and go to the ICU, they will follow the
             protocol so that the treatment due to the group to which the patient is allocated on the
             day after the surgery begins.
  
             It should be noted that the pilot study should only be started after approval by CEP.
  
             After completion of the pilot study, there will be an evaluation of the entire protocol
             so that possible flaws can be corrected before definitive collection.
  
          5. th Phase: Data collection It will consist of collecting data from patients in the
             post-randomization intervention and allocation of patients to a group, following the
             procedures of the protocol.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Pacients will be divided into 3 groups (CPAP group - CPAP + usual physical therapy care, BiPAP group - BiPAP + usual physical therapy care, and Control group - usual physical therapy care) in a 1:1 allocation ratio. Control group will receive the usual physiotherapy treatment, as kinesiotherapy protocol. Treatment will be administered twice a day, starting in the ICU and progressing to the ward. In the CPAP group, nasal CPAP at 10cmH2O will be administered for 1 hour, twice a day, using an approved device. In BiPAP group, nasal BiPAP with IPAP of 13cmH2O and EPAP of 8cmH2O will be administered for 1 hour, twice a day, using an approved device. The NIV sessions will be conducted during the 5 days of hospitalization, both in the ICU and the ward. After the fifth day, patients in intervention groups will undergo reassessment using the same assessment instruments as before.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: This is a single-center, randomized, controlled, double-blind clinical trial, in which participants and outcome evaluators were blinded.
  measure: Pulmonary function
  time frame: Day 1 and day 5
  description: All participants will undergo an evaluation by a CONTEC model spirometer (SPB80b, CHINA) to verify lung volumes and capacities. At least three tests will be performed, with a variation of less than 5% and the highest value obtained in one of the tests will be compared with the predicted values of pulmonary function parameters for the Brazilian population. FEV1 and FVC will be assessed. The predicted values will be calculated using the reference values (PEREIRA et al., 2007).
  measure: Length of hospital stay
  time frame: The length of hospital stay will be assessed and reported as the number of days from admission to discharge, measured up to 2 weeks after the date of randomization.
  description: Absolute number of days of hospitalization up to 2 weeks after the date of randomization.
  measure: Presence of lung complications
  time frame: From the date of randomization to the date of the first documented progression or the date of death from any cause, whichever occurs first, measured up to 2 weeks after the date of hospital discharge.
  description: assessment of the occurrence or absence of any complications related to the lungs during the hospitalization period.cause, whichever occurs first, measured up to 2 weeks
  measure: Score of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) in Portuguese version
  time frame: Day 1 and Day 5
  description: The Portuguese version of the MLHFQ will be used to assess the patient's quality of life. The questionnaire provides a final score as a metric, and the change in score over the treatment period will be evaluated. The MLHFQ score is a measure of health-related quality of life in patients with heart failure. The higher the score, the greater the negative impact of heart failure on the patient's quality of life. A score of 0 indicates that the patient has no limitations or problems related to heart failure, while a score of 105 indicates a maximum limitation or problem in all areas assessed by the questionnaire.
  measure: Funcional capacity
  time frame: Day 1 and Day 5
  description: The TUG test will be performed to assess functional capacity. The patient will start from a sitting position, walk quickly for 3 meters, turn 180 degrees, and return to the chair. The time taken, measured from standing up to completely leaning the trunk against the chair, will be recorded. Time values below 10 seconds indicate maximum functionality, 10 to 19 seconds indicate functional independence, 20 seconds and above indicate some functional limitation, and 30 seconds and above indicate significant functional limitation.
  measure: The global perception of change scale
  time frame: Day 1 and Day 5
  description: The GPCS is a self-report tool that assesses an individual's perception of change in a specific domain. It uses Likert-scale items ranging from "a very great deal worse/less" to "a very great deal better/more" to capture subjective information about perceived change.
  measure: The functional independence measure (MIF)
  time frame: Day 1 and Day 5
  description: The MIF questionnaire will be administered preoperatively and on the sixth day to assess functional independence.
  measure: pO2 (partial pressure of oxygen)
  time frame: Days 1 and 2.
  description: Partial pressure of oxygen (PO2) is a key physiological parameter that measures the pressure exerted solely by oxygen molecules in a mixture of gases, such as air or blood. It is an important indicator of the oxygen-carrying capacity and oxygen exchange efficiency in the respiratory system (ROCA et al. 2020). PO2 will be measured in millimeters of mercury (mmHg) (BAI, et al. 2020)
  measure: pCO2 (partial pressure of carbon dioxide)
  time frame: Days 1 and 2.
  description: Partial pressure of carbon dioxide (pCO2) is a fundamental physiological parameter that measures the pressure exerted solely by carbon dioxide molecules in a mixture of gases, such as air or blood. It plays a crucial role in the regulation of acid-base balance and respiratory function.
  The unit of measurement for pCO2 will be expressed in millimeters of mercury (mmHg).(RODRIGUEZ, 2006)
  measure: HCO3 (bicarbonate)
  time frame: Days 1 and 2.
  description: Bicarbonate (HCO3) is an important physiological parameter that measures the concentration of bicarbonate ions in the blood. It is a vital component of the body's acid-base balance and plays a crucial role in maintaining the pH of the blood within a normal range.
  The unit of measurement for bicarbonate will be expressed in milliequivalents per liter (mEq/L) (CHUA, 2011).
  measure: Arterial Oxygen Saturation (SaO2)
  time frame: Days 1 and 2.
  description: Arterial Oxygen Saturation (SaO2) is a critical physiological parameter that measures the percentage of hemoglobin in arterial blood that is bound with oxygen. It reflects the efficiency of oxygen transport from the lungs to the body's tissues.
  The unit of measurement for SaO2 is typically expressed as a percentage (%). (CASTRO, et al, 2022)
  measure: Base Excess (BE)
  time frame: Days 1 and 2.
  description: Base Excess (BE) is a significant physiological parameter that measures the amount of excess or deficit of base (bicarbonate) in the blood, indicating the body's acid-base balance. It quantifies the deviation of the blood's buffering capacity from the normal range, which helps in assessing the metabolic component of acid-base disturbances.
  The unit of measurement for Base Excess will be expressed in milliequivalents per liter (mEq/L) (CASTRO, et al, 2022)
  measure: Duration of Cardiopulmonary Bypass
  time frame: Day 1
  description: The duration of cardiopulmonary bypass during the cardiac surgery. • Unit of Measure: minutes
  measure: Type of Surgery
  time frame: Day 1
  description: The specific type of cardiac surgery performed. • Unit of Measure: N/A (Categorical Variable)
  measure: Personal History
  time frame: Day 1
  description: Relevant information about the patient's personal medical history. • Unit of Measure: N/A (Categorical Variable)
  measure: Preoperative Ejection Fraction
  time frame: Day 1
  description: The percentage of preoperative cardiac ejection fraction.• Unit of Measure: percentage (%)
  measure: Previous Respiratory Complications
  time frame: Day 1
  description: Indication of the presence or absence of previous respiratory complications. • Unit of Measure: N/A (Categorical Variable)
  measure: Body Mass Index (BMI)
  time frame: Day 1
  description: The patient's body mass index, calculated as weight (in kg) divided by the square of height (in meters). Unit of Measure: N/A (Calculated from weight and height)
  measure: Gender
  time frame: Day 1
  description: The patient's gender (male or female). Unit of Measure: N/A (Categorical Variable)
  measure: Age
  time frame: Day 1
  description: The patient's age in years
  arm group label: Control group 1 (usual care)
  arm group type: Active Comparator
  description: Patients undergo physiotherapy treatment twice daily, transitioning from the ICU to the ward. The treatment plan spans several days, starting on the first postoperative day after ICU discharge. In the ICU, Day 1 includes diaphragmatic breathing exercises, coughing stimulus, upper limb exercises (shoulder flexion/extension, abduction), and lower limb exercises (thigh flexion, dorsiflexion/plantarflexion). Day 2 involves diaphragmatic breathing, coughing stimulus, upper limb exercises, lower limb exercises, cycling for 3 minutes, and respiratory device exercises. Upon moving to the ward on Day 3, patients perform diaphragmatic breathing, coughing stimulus, upper limb exercises, lower limb exercises, and a 5-minute walk. Day 4 focuses on diaphragmatic breathing, coughing stimulus, and a 10-minute walk. Finally, on Day 5, patients engage in diaphragmatic breathing, coughing stimulus, and a 15-minute walk.
  arm group label: Intervention group 2 (CPAP)
  arm group type: Experimental
  description: They will be submitted to the same care as the control group, adding NIV with nasal CPAP 10cmH2O for 1 hour using device and brand approved by ANVISA, during the 5 days of hospitalization, both in the ICU and in the ward. The frequency of the sessions will be two (2) per day, in the morning and in the afternoon. Flexibility of time for carrying out the procedure is also planned, since in a hospital environment the patient can often undergo exams, other behaviors that may make it difficult to apply the protocol at the initially scheduled time. After the fifth day, the patient will be reassessed with the same instruments reported.
  arm group label: Intervention group 2 (BIPAP):
  arm group type: Experimental
  description: They will undergo the same care as the control group, adding NIV with nasal BIPAP with IPAP of 13cmH2O and EPAP 8 cmH2O for 1 hour, using equipment and brand approved by ANVISA, during the 5 days of hospitalization, both in the ICU and in the ward . The frequency of the sessions will be two (2) per day, in the morning and in the afternoon. Flexibility of time for carrying out the procedure is also planned, since in a hospital environment the patient can often undergo exams, other behaviors that may make it difficult to apply the protocol at the initially scheduled time. After the fifth day, the patient will be reassessed with the same instruments reported.
  intervention type: Procedure
  intervention name: CPAP
  description: Use of non-invasive ventilation in patients in group 2 with CPAP.
  arm group label: Intervention group 2 (CPAP)
  intervention type: Procedure
  intervention name: BIPAP
  description: Use of non-invasive ventilation in patients in group 3 with BIPAP.
  arm group label: Intervention group 2 (BIPAP):
  intervention type: Procedure
  intervention name: Usual care in phisicaltherapy
  description: Patients undergoing usual physiotherapy treatment, consisting of a kinesiotherapy protocol
  arm group label: Control group 1 (usual care)
  arm group label: Intervention group 2 (BIPAP):
  arm group label: Intervention group 2 (CPAP)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Eder R Araújo, doctoral
  phone: +5583988998813
  email: eder.rodrigues.araujo@gmail.com
  last name: Patrícia Nogueira, doctor
  phone: +5584988777454
  email: idpa02@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Brazil
  citation: Hossen A, Jaju D, Al-Abri M, Al-Sabti H, Mukaddirov M, Hassan M, Al-Hashmi K. Investigation of heart rate variability of patients undergoing coronary artery bypass grafting (CABG). Technol Health Care. 2017;25(2):197-210. doi: 10.3233/THC-161260.
  PMID: 28387685
  citation: Du H, Newton PJ, Salamonson Y, Carrieri-Kohlman VL, Davidson PM. A review of the six-minute walk test: its implication as a self-administered assessment tool. Eur J Cardiovasc Nurs. 2009 Mar;8(1):2-8. doi: 10.1016/j.ejcnurse.2008.07.001. Epub 2008 Aug 9.
  PMID: 18694656
  citation: Shakouri SK, Salekzamani Y, Taghizadieh A, Sabbagh-Jadid H, Soleymani J, Sahebi L, Sahebi R. Effect of respiratory rehabilitation before open cardiac surgery on respiratory function: a randomized clinical trial. J Cardiovasc Thorac Res. 2015;7(1):13-7. doi: 10.15171/jcvtr.2015.03. Epub 2015 Mar 29.
  PMID: 25859310
  citation: Valkenet K, de Heer F, Backx FJ, Trappenburg JC, Hulzebos EH, Kwant S, van Herwerden LA, van de Port IG. Effect of inspiratory muscle training before cardiac surgery in routine care. Phys Ther. 2013 May;93(5):611-9. doi: 10.2522/ptj.20110475. Epub 2013 Jan 3.
  PMID: 23288909
  citation: Dos Santos TD, Pereira SN, Portela LOC, Cardoso DM, Lago PD, Dos Santos Guarda N, Moresco RN, Pereira MB, de Albuquerque IM. Moderate-to-high intensity inspiratory muscle training improves the effects of combined training on exercise capacity in patients after coronary artery bypass graft surgery: A randomized clinical trial. Int J Cardiol. 2019 Mar 15;279:40-46. doi: 10.1016/j.ijcard.2018.12.013. Epub 2018 Dec 10.
  PMID: 30581100
  citation: American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
  PMID: 12186831
  citation: Carvalho VO, Guimaraes GV, Carrara D, Bacal F, Bocchi EA. Validation of the Portuguese version of the Minnesota Living with Heart Failure Questionnaire. Arq Bras Cardiol. 2009 Jul;93(1):39-44. doi: 10.1590/s0066-782x2009000700008. English, Portuguese, Spanish.
  PMID: 19838469
  citation: 8. Vieira WO, Barbosa LK, Bezerra AS, et al. Test timed up and go and its correlation with age and functional exercise capacity in asymptomatic women. Fisioterapia em Movimento. 2017;30(3):463-471. doi:10.1590/1980-5918.030.003.AO04.
  citation: Bretan O, Silva Junior JE, Ribeiro OR, Corrente JE. Risk of falling among elderly persons living in the community: assessment by the Timed up and go test. Braz J Otorhinolaryngol. 2013 Jan-Feb;79(1):18-21. doi: 10.5935/1808-8694.20130004.
  PMID: 23503902
  citation: Behlouli H, Feldman DE, Ducharme A, Frenette M, Giannetti N, Grondin F, Michel C, Sheppard R, Pilote L. Identifying relative cut-off scores with neural networks for interpretation of the Minnesota Living with Heart Failure questionnaire. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6242-6. doi: 10.1109/IEMBS.2009.5334659.
  PMID: 19965089
  citation: Bai C, Chotirmall SH, Rello J, Alba GA, Ginns LC, Krishnan JA, Rogers R, Bendstrup E, Burgel PR, Chalmers JD, Chua A, Crothers KA, Duggal A, Kim YW, Laffey JG, Luna CM, Niederman MS, Raghu G, Ramirez JA, Riera J, Roca O, Tamae-Kakazu M, Torres A, Watkins RR, Barrecheguren M, Belliato M, Chami HA, Chen R, Cortes-Puentes GA, Delacruz C, Hayes MM, Heunks LMA, Holets SR, Hough CL, Jagpal S, Jeon K, Johkoh T, Lee MM, Liebler J, McElvaney GN, Moskowitz A, Oeckler RA, Ojanguren I, O'Regan A, Pletz MW, Rhee CK, Schultz MJ, Storti E, Strange C, Thomson CC, Torriani FJ, Wang X, Wuyts W, Xu T, Yang D, Zhang Z, Wilson KC. Updated guidance on the management of COVID-19: from an American Thoracic Society/European Respiratory Society coordinated International Task Force (29 July 2020). Eur Respir Rev. 2020 Oct 5;29(157):200287. doi: 10.1183/16000617.0287-2020. Print 2020 Sep 30.
  PMID: 33020069
  citation: Rodriguez P, Lellouche F, Aboab J, Buisson CB, Brochard L. Transcutaneous arterial carbon dioxide pressure monitoring in critically ill adult patients. Intensive Care Med. 2006 Feb;32(2):309-312. doi: 10.1007/s00134-005-0006-4. Epub 2006 Jan 31.
  PMID: 16450093
  citation: Chua HR, Schneider A, Bellomo R. Bicarbonate in diabetic ketoacidosis - a systematic review. Ann Intensive Care. 2011 Jul 6;1(1):23. doi: 10.1186/2110-5820-1-23.
  PMID: 21906367
  citation: Castro D, Patil SM, Keenaghan M. Arterial Blood Gas. 2022 Sep 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536919/
  PMID: 30725604
  responsible party type: Principal Investigator
  investigator affiliation: Universidade Federal do Rio Grande do Norte
  investigator full name: Patri-cia Angelica de Miranda Silva Nogueira
  investigator title: Head professor of physiotherapy course and pós-graduate course.
  sharing ipd: No