<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/NCT04499027</url>
  </required_header>
  <id_info>
    <org_study_id>D230</org_study_id>
    <nct_id>NCT04499027</nct_id>
  </id_info>
  <brief_title>Prognostic Value of Lung Ultrasound in Predicting Intensive Care Unit Length of Stay in Adult Cardiac Surgery</brief_title>
  <official_title>Prognostic Value of Lung Ultrasound in Predicting Intensive Care Unit Length of Stay in Adult Cardiac Surgery: A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fayoum University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fayoum University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Being easy, bedside, non-expensive, noninvasive and radiation free, there has been a growing&#xD;
      interest in the implementation of lung ultrasound in critical care management in the last&#xD;
      decade, cardiac surgery was not an exception in both adult and pediatric surgeries Many&#xD;
      predictors for open heart surgery outcomes have been studied in past years including The&#xD;
      Society of Thoracic Surgeons (STS) risk score and the EuroSCORE (ES), preoperative clinical&#xD;
      condition, associated chronic diseases, type of surgery, age, duration of cardiopulmonary&#xD;
      bypass and brain natriuretic peptide (BNP), cystatin-C A recent study described the use of a&#xD;
      novel postoperative lung ultrasound score scanning for B lines which denote subpleural&#xD;
      interstitial edema in various lung regions for predicting critical care length of stay in&#xD;
      pediatric cardiac surgeries.&#xD;
&#xD;
      The objective of the current study is to evaluate the role of the new lung ultrasound score&#xD;
      in predicting the length of postoperative intensive care stay after adult open heart&#xD;
      surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval of the local institutional ethics committee and local institutional review&#xD;
      board. All patients scheduled for open heart surgery in Fayoum university hospital starting&#xD;
      from August 2020 will be enrolled in this prospective observational study until fulfilling&#xD;
      sample size. A detailed informed consent will be signed by the eligible participants before&#xD;
      recruitment ANESTHETIC TECHNIQUE All patients will be preoperatively assessed and&#xD;
      investigated by complete blood count, coagulation profile, Liver and kidney functions and&#xD;
      serum electrolytes. Chest X-ray, Electrocardiography (ECG) and echocardiography will be&#xD;
      routinely done. Coronary angiography and carotid arterial duplex will be requested if needed.&#xD;
&#xD;
      Patient will be premedicated by 10 mg morphine intramuscularly at morning of the operation.&#xD;
      Prior to induction of anesthesia, standard monitoring will be applied including a five-lead&#xD;
      electrocardiography system, a pulse oximeter probe. A peripheral intravenous (IV) cannula&#xD;
      will be placed. An arterial will be inserted using a 20 G cannula either right or left radial&#xD;
      artery under local anesthesia. After pre-oxygenation, general anesthesia will be induced&#xD;
      using midazolam 2-5 mg, fentanyl (3-10 μg/kg), propofol (1-1.5 mg/Kg), followed by atracurium&#xD;
      (0.5 mg/kg).&#xD;
&#xD;
      After trachea intubation, patients will be mechanically ventilated with oxygen in air so as&#xD;
      to achieve normocarbia. A main stream capnogram, an esophageal temperature probe and a Foley&#xD;
      catheter will also be placed. A triple-lumen central venous catheter will be placed usually&#xD;
      through the right internal jugular vein.&#xD;
&#xD;
      Maintenance of anesthesia will be achieved by inhaled Isoflurane 0.4 to 1% and atracurium&#xD;
      infusion at a rate of 0.5 mg/kg/h. After initiating extracorporeal circulation, Propofol&#xD;
      infusion at a rate of 50-100 µg/kg/min will be added to replace isoflurane inhalation.&#xD;
&#xD;
      Patients will receive intravenous heparin (300-500 IU/kg body weight) before the initiation&#xD;
      of cardiopulmonary bypass (CPB) to achieve an activated clotting time (ACT) of more than 480&#xD;
      seconds. Cardiopulmonary bypass was instituted with the use of a non-pulsatile blood flow at&#xD;
      2.4 L/min/m2, a non-heparin-coated circuit, and a membrane oxygenator. Mean arterial pressure&#xD;
      will be adjusted to exceed 60mmHg before, during and after cardiopulmonary bypass (CBP) .&#xD;
      Cardiac arrest will be induced using St Thomas crystalloid solution (Hamburg). Lactated&#xD;
      Ringer's solution will be added to the CPB circuit to maintain reservoir volume if needed,&#xD;
      and packed red blood cells will be infused when hemoglobin level drops to less than 7g/dl.&#xD;
      After rewarming the patient to 37°C and weaning from CPB; Protamine sulfate will be used to&#xD;
      reverse the effect of heparin.&#xD;
&#xD;
      After skin closure and wound dressing, patients will be transferred to the intensive care&#xD;
      unit intubated with manual ventilation and full monitoring during transfer.&#xD;
&#xD;
      Intensive care Tracheal extubation will be performed when the patient meets the following&#xD;
      criteria: awake or arousable, hemodynamically stable, no ongoing active bleeding, warm&#xD;
      extremities, no electrolyte abnormalities, no or minimal inotropic support and a satisfactory&#xD;
      arterial blood gas with a fraction of inspired oxygen (FiO2) &lt; 0.5, Ventilator pressure&#xD;
      support reduced to 10 CmH2O with Positive End Expiratory Pressure (PEEP) 5-7 CmH2O.&#xD;
&#xD;
      ICU management and decisions will be left to the intensivist who is responsible of the&#xD;
      postoperative cardiac critical care.&#xD;
&#xD;
      Patient will be discharged from ICU when the following criteria are met: Awake patient with&#xD;
      oxygen saturation (SpO2) &lt; 90% at FIO2 &gt; 0.5 by facemask, adequate cardiac stability, no&#xD;
      intravenous inotropic or vasopressor supportive therapy, no hemodynamically significant&#xD;
      arrhythmia, not dependent on epicardial external pacing no major bleeding i.e. chest tube&#xD;
      drainage less than 50 ml/h, urine output of more than 0.5 ml/kg/h and no vital threats to&#xD;
      other organ systems such as kidneys and liver.&#xD;
&#xD;
      Lung Ultrasound scan (LUS) All patients will be examined at 12 hours postoperatively as per&#xD;
      our institution routine using a convex ultrasound probe, any other LUS will be done upon&#xD;
      demand.&#xD;
&#xD;
      LUS will be performed by an experienced radiologist according to standardized protocols.&#xD;
&#xD;
      This will be used to calculate total LUS-score (calculated as a sum of all quadrants score)&#xD;
      and individual areas score.&#xD;
&#xD;
      Sample size was calculated using (G power). Minimal sample size of patients was 191 needed to&#xD;
      get power level 0.80, alpha level 0.05 (two tailed) and 0.20 as expected β (slope of&#xD;
      regression line) for predicting intensive care Length of stay .&#xD;
&#xD;
      Data management will be performed using the Statistical Package for Social Sciences (version&#xD;
      22.0; SPSS Inc., Chicago, IL, USA). Descriptive statistics (mean, standard deviation for&#xD;
      quantitative data, and number and percentages for qualitative data) will be used to summarize&#xD;
      the data. Nominal data will be analyzed using simple chi squared test, while independent&#xD;
      sample t-test or one-way ANOVA procedure will be used to compare means for two or three&#xD;
      groups of cases, respectively. Regression analysis will be performed to determine the&#xD;
      predictors for LOS. A probability value (P value) ≤ 0.05 is considered significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2020</start_date>
  <completion_date type="Actual">July 30, 2022</completion_date>
  <primary_completion_date type="Actual">July 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intensive care Length of stay</measure>
    <time_frame>from ICU admission till patient discharge to ward assessed up to 30 days</time_frame>
    <description>in days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EURO Score II</measure>
    <time_frame>24 hours before operation</time_frame>
    <description>calculated preoperatively using different variables which are age, gender, renal impairment, extracardiac arteriopathy, poor mobility, previous cardiac surgery, chronic lung disease, critical preoperative state, presence of insulin dependent diabetes, New York Heart Association (NYHA) classification, Canadian cardiovascular society (CCS) class, left ventricular function, recent myocardial infarction, pulmonary hypertension, urgency and weight of the operation and whether thoracic aorta is involved in surgery.18 Score will be calculated using an online calculator by QxMD website.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>previous associated comorbidities</measure>
    <time_frame>24 hours before operation</time_frame>
    <description>Diabetes, hypertension, chronic renal failure, liver impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>primary pathology</measure>
    <time_frame>24 hours before operation</time_frame>
    <description>Coronary artery disease, valvular heart disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>planned operative procedure</measure>
    <time_frame>24 hours before operation</time_frame>
    <description>Coronary artery bypass graft, valve replacement, Ventricular Septal Defect repair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>liver enzymes</measure>
    <time_frame>24 hours before operation and 1 hour after operation</time_frame>
    <description>ALT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sodium level</measure>
    <time_frame>24 hours before operation and 1 hour after operation</time_frame>
    <description>before and after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>potassium level</measure>
    <time_frame>24 hours before operation and 1 hour after operation</time_frame>
    <description>before and after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>creatinine</measure>
    <time_frame>24 hours before operation and 1 hour after operation</time_frame>
    <description>before and after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urea</measure>
    <time_frame>24 hours before operation and 1 hour after operation</time_frame>
    <description>before and after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemoglobin</measure>
    <time_frame>24 hours before operation and 1 hour after operation</time_frame>
    <description>before and after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>platelet count</measure>
    <time_frame>24 hours before operation and 1 hour after operation</time_frame>
    <description>before and after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>prothrombin concentration</measure>
    <time_frame>24 hours before operation and 1 hour after operation</time_frame>
    <description>before and after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>prothrombin time</measure>
    <time_frame>24 hours before operation and 1 hour after operation</time_frame>
    <description>before and after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiopulmonary Bypass (CPB) time</measure>
    <time_frame>assessed at the end of CBP up to 12 hours from start of operation</time_frame>
    <description>in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concomitant vasoactive medications</measure>
    <time_frame>assessed at te end of the operation up to 12 hours from the start of the operation</time_frame>
    <description>Noradrenaline, adrenaline, dobutamine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial blood gas values</measure>
    <time_frame>assessed up to 24 after the end of operation</time_frame>
    <description>baseline after induction , before and after weaning from CBP and postoperatively in critical care with LUS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra and post-operative invasive BP</measure>
    <time_frame>assessed up to 24 hours postoperatively</time_frame>
    <description>(invasive BP measured in mmhg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra and post-operative heart rate</measure>
    <time_frame>assessed up to 24 hours postoperatively</time_frame>
    <description>Heart rate measured in beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative total LUS score</measure>
    <time_frame>assessed 12 hours after the end of the operation</time_frame>
    <description>as a sum af all areas assessed by ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>individual lung areas score</measure>
    <time_frame>assessed 12 hours after the end of the operation</time_frame>
    <description>(Anterior, Lateral and Posterior).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>extubation time</measure>
    <time_frame>assessed up to 30 days</time_frame>
    <description>time from ICU admission till Endotracheal tube removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>in-hospital mortality</measure>
    <time_frame>until patient discharge assessed up to 30 days</time_frame>
    <description>death before hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative complications</measure>
    <time_frame>assessed until patient discharge or up to 30 days postoperatively</time_frame>
    <description>Myocardial infarction, atrial fibrillations, Cerebral stroke or bleeding, GI bleeding</description>
  </secondary_outcome>
  <enrollment type="Actual">191</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Valvular Heart Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lung ultrasound scan</intervention_name>
    <description>12 hours postoperatively using a convex ultrasound probe LUS will be performed by an experienced radiologist according to standardized protocols. For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines will be identified. Each one will be divided into upper and lower halves, making a sum of 6 different quadrants for each side: anterior superior, anterior inferior, lateral superior, lateral inferior, posterior superior, posterior inferior.&#xD;
For each quadrant a score will be assigned based on B lines which are defined as comet like artifacts indicating subpleural interstitial edema as follows:&#xD;
(0) normal aeration: A lines with lung sliding or fewer than two isolated B lines; (1) moderate loss of lung aeration: well-defined, multiple B lines ; (2) severe loss of lung aeration: multiple coalescent B lines; and (3) complete loss of lung aeration or lung consolidation.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients admitted in Fayoum uniersity hospital who are candidates for open heart surgeries&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients Scheduled for elective cardiac surgery for valve replacement, CABG or&#xD;
             adult congenital (VSD or ASD) via median sternotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects with inadequate acoustic windows or incomplete examinations (as defined&#xD;
             below),&#xD;
&#xD;
          -  Patients with emergency surgeries.&#xD;
&#xD;
          -  Patients with thoracic deformities or preexisting pulmonary pathology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed A Hamed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of medicine, Fayoum university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fayoum University hospital</name>
      <address>
        <city>Madīnat al Fayyūm</city>
        <state>Faiyum Governorate</state>
        <zip>63514</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://qxmd.com/calculate/calculator_285/euroscore-ii</url>
    <description>Euro score II</description>
  </link>
  <reference>
    <citation>Cantinotti M, Giordano R, Volpicelli G, Kutty S, Murzi B, Assanta N, Gargani L. Lung ultrasound in adult and paediatric cardiac surgery: is it time for routine use? Interact Cardiovasc Thorac Surg. 2016 Feb;22(2):208-15. doi: 10.1093/icvts/ivv315. Epub 2015 Nov 18.</citation>
    <PMID>26586677</PMID>
  </reference>
  <reference>
    <citation>Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019 Mar 15;199(6):701-714. doi: 10.1164/rccm.201802-0236CI. Erratum In: Am J Respir Crit Care Med. 2020 Apr 15;201(8):1015. Am J Respir Crit Care Med. 2020 Jun 1;201(11):1454.</citation>
    <PMID>30372119</PMID>
  </reference>
  <reference>
    <citation>Bouabdallaoui N, Stevens SR, Doenst T, Petrie MC, Al-Attar N, Ali IS, Ambrosy AP, Barton AK, Cartier R, Cherniavsky A, Demondion P, Desvigne-Nickens P, Favaloro RR, Gradinac S, Heinisch P, Jain A, Jasinski M, Jouan J, Kalil RAK, Menicanti L, Michler RE, Rao V, Smith PK, Zembala M, Velazquez EJ, Al-Khalidi HR, Rouleau JL; STICH Trial Investigators. Society of Thoracic Surgeons Risk Score and EuroSCORE-2 Appropriately Assess 30-Day Postoperative Mortality in the STICH Trial and a Contemporary Cohort of Patients With Left Ventricular Dysfunction Undergoing Surgical Revascularization. Circ Heart Fail. 2018 Nov;11(11):e005531. doi: 10.1161/CIRCHEARTFAILURE.118.005531.</citation>
    <PMID>30571194</PMID>
  </reference>
  <reference>
    <citation>Wynne R. Variable definitions: implications for the prediction of pulmonary complications after adult cardiac surgery. Eur J Cardiovasc Nurs. 2004 Apr;3(1):43-52. doi: 10.1016/j.ejcnurse.2003.11.001.</citation>
    <PMID>15053887</PMID>
  </reference>
  <reference>
    <citation>Rouby JJ, Arbelot C, Gao Y, Zhang M, Lv J, An Y, Chunyao W, Bin D, Valente Barbas CS, Dexheimer Neto FL, Prior Caltabeloti F, Lima E, Cebey A, Perbet S, Constantin JM; APECHO Study Group. Training for Lung Ultrasound Score Measurement in Critically Ill Patients. Am J Respir Crit Care Med. 2018 Aug 1;198(3):398-401. doi: 10.1164/rccm.201802-0227LE. No abstract available.</citation>
    <PMID>29557671</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>October 18, 2022</last_update_submitted>
  <last_update_submitted_qc>October 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fayoum University Hospital</investigator_affiliation>
    <investigator_full_name>Mohamed Ahmed Hamed</investigator_full_name>
    <investigator_title>Associate professor of Amesthesiology</investigator_title>
  </responsible_party>
  <keyword>Lung ultrasound</keyword>
  <keyword>coronary artery bypass graft (CABG)</keyword>
  <keyword>open heart surgery</keyword>
  <keyword>ICU LOS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Valve Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04499027
org study id: D230
nct id: NCT04499027
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Being easy, bedside, non-expensive, noninvasive and radiation free, there has been a growing
      interest in the implementation of lung ultrasound in critical care management in the last
      decade, cardiac surgery was not an exception in both adult and pediatric surgeries Many
      predictors for open heart surgery outcomes have been studied in past years including The
      Society of Thoracic Surgeons (STS) risk score and the EuroSCORE (ES), preoperative clinical
      condition, associated chronic diseases, type of surgery, age, duration of cardiopulmonary
      bypass and brain natriuretic peptide (BNP), cystatin-C A recent study described the use of a
      novel postoperative lung ultrasound score scanning for B lines which denote subpleural
      interstitial edema in various lung regions for predicting critical care length of stay in
      pediatric cardiac surgeries.

      The objective of the current study is to evaluate the role of the new lung ultrasound score
      in predicting the length of postoperative intensive care stay after adult open heart
      surgeries.
After approval of the local institutional ethics committee and local institutional review
      board. All patients scheduled for open heart surgery in Fayoum university hospital starting
      from August 2020 will be enrolled in this prospective observational study until fulfilling
      sample size. A detailed informed consent will be signed by the eligible participants before
      recruitment ANESTHETIC TECHNIQUE All patients will be preoperatively assessed and
      investigated by complete blood count, coagulation profile, Liver and kidney functions and
      serum electrolytes. Chest X-ray, Electrocardiography (ECG) and echocardiography will be
      routinely done. Coronary angiography and carotid arterial duplex will be requested if needed.

      Patient will be premedicated by 10 mg morphine intramuscularly at morning of the operation.
      Prior to induction of anesthesia, standard monitoring will be applied including a five-lead
      electrocardiography system, a pulse oximeter probe. A peripheral intravenous (IV) cannula
      will be placed. An arterial will be inserted using a 20 G cannula either right or left radial
      artery under local anesthesia. After pre-oxygenation, general anesthesia will be induced
      using midazolam 2-5 mg, fentanyl (3-10 μg/kg), propofol (1-1.5 mg/Kg), followed by atracurium
      (0.5 mg/kg).

      After trachea intubation, patients will be mechanically ventilated with oxygen in air so as
      to achieve normocarbia. A main stream capnogram, an esophageal temperature probe and a Foley
      catheter will also be placed. A triple-lumen central venous catheter will be placed usually
      through the right internal jugular vein.

      Maintenance of anesthesia will be achieved by inhaled Isoflurane 0.4 to 1% and atracurium
      infusion at a rate of 0.5 mg/kg/h. After initiating extracorporeal circulation, Propofol
      infusion at a rate of 50-100 µg/kg/min will be added to replace isoflurane inhalation.

      Patients will receive intravenous heparin (300-500 IU/kg body weight) before the initiation
      of cardiopulmonary bypass (CPB) to achieve an activated clotting time (ACT) of more than 480
      seconds. Cardiopulmonary bypass was instituted with the use of a non-pulsatile blood flow at
      2.4 L/min/m2, a non-heparin-coated circuit, and a membrane oxygenator. Mean arterial pressure
      will be adjusted to exceed 60mmHg before, during and after cardiopulmonary bypass (CBP) .
      Cardiac arrest will be induced using St Thomas crystalloid solution (Hamburg). Lactated
      Ringer's solution will be added to the CPB circuit to maintain reservoir volume if needed,
      and packed red blood cells will be infused when hemoglobin level drops to less than 7g/dl.
      After rewarming the patient to 37°C and weaning from CPB; Protamine sulfate will be used to
      reverse the effect of heparin.

      After skin closure and wound dressing, patients will be transferred to the intensive care
      unit intubated with manual ventilation and full monitoring during transfer.

      Intensive care Tracheal extubation will be performed when the patient meets the following
      criteria: awake or arousable, hemodynamically stable, no ongoing active bleeding, warm
      extremities, no electrolyte abnormalities, no or minimal inotropic support and a satisfactory
      arterial blood gas with a fraction of inspired oxygen (FiO2) < 0.5, Ventilator pressure
      support reduced to 10 CmH2O with Positive End Expiratory Pressure (PEEP) 5-7 CmH2O.

      ICU management and decisions will be left to the intensivist who is responsible of the
      postoperative cardiac critical care.

      Patient will be discharged from ICU when the following criteria are met: Awake patient with
      oxygen saturation (SpO2) < 90% at FIO2 > 0.5 by facemask, adequate cardiac stability, no
      intravenous inotropic or vasopressor supportive therapy, no hemodynamically significant
      arrhythmia, not dependent on epicardial external pacing no major bleeding i.e. chest tube
      drainage less than 50 ml/h, urine output of more than 0.5 ml/kg/h and no vital threats to
      other organ systems such as kidneys and liver.

      Lung Ultrasound scan (LUS) All patients will be examined at 12 hours postoperatively as per
      our institution routine using a convex ultrasound probe, any other LUS will be done upon
      demand.

      LUS will be performed by an experienced radiologist according to standardized protocols.

      This will be used to calculate total LUS-score (calculated as a sum of all quadrants score)
      and individual areas score.

      Sample size was calculated using (G power). Minimal sample size of patients was 191 needed to
      get power level 0.80, alpha level 0.05 (two tailed) and 0.20 as expected β (slope of
      regression line) for predicting intensive care Length of stay .

      Data management will be performed using the Statistical Package for Social Sciences (version
      22.0; SPSS Inc., Chicago, IL, USA). Descriptive statistics (mean, standard deviation for
      quantitative data, and number and percentages for qualitative data) will be used to summarize
      the data. Nominal data will be analyzed using simple chi squared test, while independent
      sample t-test or one-way ANOVA procedure will be used to compare means for two or three
      groups of cases, respectively. Regression analysis will be performed to determine the
      predictors for LOS. A probability value (P value) ≤ 0.05 is considered significant.
observational model: Cohort
time perspective: Prospective
measure: Intensive care Length of stay
time frame: from ICU admission till patient discharge to ward assessed up to 30 days
description: in days
measure: EURO Score II
time frame: 24 hours before operation
description: calculated preoperatively using different variables which are age, gender, renal impairment, extracardiac arteriopathy, poor mobility, previous cardiac surgery, chronic lung disease, critical preoperative state, presence of insulin dependent diabetes, New York Heart Association (NYHA) classification, Canadian cardiovascular society (CCS) class, left ventricular function, recent myocardial infarction, pulmonary hypertension, urgency and weight of the operation and whether thoracic aorta is involved in surgery.18 Score will be calculated using an online calculator by QxMD website.
measure: previous associated comorbidities
time frame: 24 hours before operation
description: Diabetes, hypertension, chronic renal failure, liver impairment
measure: primary pathology
time frame: 24 hours before operation
description: Coronary artery disease, valvular heart disease
measure: planned operative procedure
time frame: 24 hours before operation
description: Coronary artery bypass graft, valve replacement, Ventricular Septal Defect repair
measure: liver enzymes
time frame: 24 hours before operation and 1 hour after operation
description: ALT
measure: sodium level
time frame: 24 hours before operation and 1 hour after operation
description: before and after the operation
measure: potassium level
time frame: 24 hours before operation and 1 hour after operation
description: before and after the operation
measure: creatinine
time frame: 24 hours before operation and 1 hour after operation
description: before and after the operation
measure: urea
time frame: 24 hours before operation and 1 hour after operation
description: before and after the operation
measure: hemoglobin
time frame: 24 hours before operation and 1 hour after operation
description: before and after the operation
measure: platelet count
time frame: 24 hours before operation and 1 hour after operation
description: before and after the operation
measure: prothrombin concentration
time frame: 24 hours before operation and 1 hour after operation
description: before and after the operation
measure: prothrombin time
time frame: 24 hours before operation and 1 hour after operation
description: before and after the operation
measure: Cardiopulmonary Bypass (CPB) time
time frame: assessed at the end of CBP up to 12 hours from start of operation
description: in minutes
measure: Concomitant vasoactive medications
time frame: assessed at te end of the operation up to 12 hours from the start of the operation
description: Noradrenaline, adrenaline, dobutamine
measure: Arterial blood gas values
time frame: assessed up to 24 after the end of operation
description: baseline after induction , before and after weaning from CBP and postoperatively in critical care with LUS
measure: Intra and post-operative invasive BP
time frame: assessed up to 24 hours postoperatively
description: (invasive BP measured in mmhg
measure: Intra and post-operative heart rate
time frame: assessed up to 24 hours postoperatively
description: Heart rate measured in beats per minute
measure: Postoperative total LUS score
time frame: assessed 12 hours after the end of the operation
description: as a sum af all areas assessed by ultrasound
measure: individual lung areas score
time frame: assessed 12 hours after the end of the operation
description: (Anterior, Lateral and Posterior).
measure: extubation time
time frame: assessed up to 30 days
description: time from ICU admission till Endotracheal tube removal
measure: in-hospital mortality
time frame: until patient discharge assessed up to 30 days
description: death before hospital discharge
measure: Post-operative complications
time frame: assessed until patient discharge or up to 30 days postoperatively
description: Myocardial infarction, atrial fibrillations, Cerebral stroke or bleeding, GI bleeding
intervention type: Diagnostic Test
intervention name: Lung ultrasound scan
description: 12 hours postoperatively using a convex ultrasound probe LUS will be performed by an experienced radiologist according to standardized protocols. For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines will be identified. Each one will be divided into upper and lower halves, making a sum of 6 different quadrants for each side: anterior superior, anterior inferior, lateral superior, lateral inferior, posterior superior, posterior inferior.
For each quadrant a score will be assigned based on B lines which are defined as comet like artifacts indicating subpleural interstitial edema as follows:
(0) normal aeration: A lines with lung sliding or fewer than two isolated B lines; (1) moderate loss of lung aeration: well-defined, multiple B lines ; (2) severe loss of lung aeration: multiple coalescent B lines; and (3) complete loss of lung aeration or lung consolidation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mohamed A Hamed, MD
role: Principal Investigator
affiliation: Faculty of medicine, Fayoum university
facility: 
country: Egypt
url: http://qxmd.com/calculate/calculator_285/euroscore-ii
description: Euro score II
citation: Cantinotti M, Giordano R, Volpicelli G, Kutty S, Murzi B, Assanta N, Gargani L. Lung ultrasound in adult and paediatric cardiac surgery: is it time for routine use? Interact Cardiovasc Thorac Surg. 2016 Feb;22(2):208-15. doi: 10.1093/icvts/ivv315. Epub 2015 Nov 18.
PMID: 26586677
citation: Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019 Mar 15;199(6):701-714. doi: 10.1164/rccm.201802-0236CI. Erratum In: Am J Respir Crit Care Med. 2020 Apr 15;201(8):1015. Am J Respir Crit Care Med. 2020 Jun 1;201(11):1454.
PMID: 30372119
citation: Bouabdallaoui N, Stevens SR, Doenst T, Petrie MC, Al-Attar N, Ali IS, Ambrosy AP, Barton AK, Cartier R, Cherniavsky A, Demondion P, Desvigne-Nickens P, Favaloro RR, Gradinac S, Heinisch P, Jain A, Jasinski M, Jouan J, Kalil RAK, Menicanti L, Michler RE, Rao V, Smith PK, Zembala M, Velazquez EJ, Al-Khalidi HR, Rouleau JL; STICH Trial Investigators. Society of Thoracic Surgeons Risk Score and EuroSCORE-2 Appropriately Assess 30-Day Postoperative Mortality in the STICH Trial and a Contemporary Cohort of Patients With Left Ventricular Dysfunction Undergoing Surgical Revascularization. Circ Heart Fail. 2018 Nov;11(11):e005531. doi: 10.1161/CIRCHEARTFAILURE.118.005531.
PMID: 30571194
citation: Wynne R. Variable definitions: implications for the prediction of pulmonary complications after adult cardiac surgery. Eur J Cardiovasc Nurs. 2004 Apr;3(1):43-52. doi: 10.1016/j.ejcnurse.2003.11.001.
PMID: 15053887
citation: Rouby JJ, Arbelot C, Gao Y, Zhang M, Lv J, An Y, Chunyao W, Bin D, Valente Barbas CS, Dexheimer Neto FL, Prior Caltabeloti F, Lima E, Cebey A, Perbet S, Constantin JM; APECHO Study Group. Training for Lung Ultrasound Score Measurement in Critically Ill Patients. Am J Respir Crit Care Med. 2018 Aug 1;198(3):398-401. doi: 10.1164/rccm.201802-0227LE. No abstract available.
PMID: 29557671
responsible party type: Principal Investigator
investigator affiliation: Fayoum University Hospital
investigator full name: Mohamed Ahmed Hamed
investigator title: Associate professor of Amesthesiology
mesh term: Coronary Artery Disease
mesh term: Heart Diseases
mesh term: Heart Valve Diseases
sharing ipd: Undecided