<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/NCT03256214</url>
  </required_header>
  <id_info>
    <org_study_id>467</org_study_id>
    <nct_id>NCT03256214</nct_id>
  </id_info>
  <brief_title>Acute Effects of Open and Closed Suction Systems in Mechanically Ventilated Patients</brief_title>
  <official_title>Acute Effects of Open and Closed Suction Systems on Pulmonary Mechanics and Cardiovascular Function in Mechanically Ventilated Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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>
      Seventy-one patients in intensive care were randomized for initial treatment with open&#xD;
      suction systems or closed suction systems in a cross-over design. Pulmonary and&#xD;
      cardiovascular physiology was assessed immediately before and after three 10-second&#xD;
      aspirations per suction. Were analyzed the effect of each suction system on physiologic&#xD;
      parameters while adjusting for their respective values prior to suction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Participants. The sample consisted of 71 subjects, both genders, hospitalized in&#xD;
      intensive care units. This study protocol was approved by the Research Ethics Committee of&#xD;
      Heliopolis Hospital - Sao Paulo - Brazil.&#xD;
&#xD;
      Patients were randomized in the following way: patients hospitalized in the odd beds of ICU&#xD;
      were aspirated initially by open suction system (OSS) and later by the closed suction system&#xD;
      (CSS); patients hospitalized in the even beds were aspirated by CSS, initially, and&#xD;
      subsequently by the OSS.&#xD;
&#xD;
      Cardiopulmonary measures: Eligible patients were evaluated for the presence or absence of&#xD;
      neural stimulation to spontaneous ventilation (drive breathing). If the patients showed&#xD;
      spontaneous respiratory movements, they were sedated to the level four of Ramsay scale. After&#xD;
      this initial evaluation, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean&#xD;
      blood pressure (MBP), heart rate (HR), respiratory rate (RR), oxygen saturation (SAT), tidal&#xD;
      volume (Vt), peak pressure (Ppeak), plateau pressure (Pplat), positive end expiratory&#xD;
      pressure (PEEP), and inspiratory flow (V) were measured. The HR and SAT data were collected&#xD;
      by visualization of DX 2010 multiparameter monitor from Dixtal. SBP, DBP and MBP were&#xD;
      obtained by a single measurement provided by the same monitor. Data of peak pressure, plateau&#xD;
      pressure, positive end expiratory pressure, inspiratory flow and tidal volume were used to&#xD;
      calculate compliance (C) and airway resistance (R). Data were collected before and after&#xD;
      tracheal aspiration.&#xD;
&#xD;
      Pulmonary Suction: After the initial data were obtained, patients who were under&#xD;
      volume-controlled ventilation mode (VCV) were submitted to the first aspiration procedure&#xD;
      according to randomization described above. Patients who were under pressure-controlled&#xD;
      ventilation mode (PCV) were changed to VCV mode, respecting the individual mean tidal volume,&#xD;
      which means that the tidal volume of the patient under PCV would be used to ventilate in VCV.&#xD;
      All patients were ventilated with a Savina (Drager) mechanical ventilator. Aspiration&#xD;
      procedures and data collection were done by a health care professional unaware of the study&#xD;
      regimes or objectives. After the measurement of the initial parameters, patients underwent&#xD;
      the procedure of aspiration in an open or closed system according to the randomization&#xD;
      described above. All patients were aspirated by a system that had not been used previously.&#xD;
      The procedure was timed and required 10 seconds to insert and remove the aspiration catheter,&#xD;
      with each aspiration performed three times. The outside diameter of the aspiration catheter&#xD;
      had half the inner diameter of the endotracheal tube, and the negative pressure was adjusted&#xD;
      between 70 and 100 mmHg. At the end of the aspiration procedure, physiological assessments&#xD;
      were repeated. Patients were returned to nursing care and underwent the second procedure&#xD;
      after six hours from initial aspiration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2015</start_date>
  <completion_date type="Actual">April 17, 2017</completion_date>
  <primary_completion_date type="Actual">July 15, 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvements in Pulmonary parameters when comparing closed and open suction systems.</measure>
    <time_frame>1 day</time_frame>
    <description>Assessment of Peak Pressure (cmH20) in both closed and open suction systems.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvements in Cardiovascular parameters when comparing Closed and open suction systems.</measure>
    <time_frame>1 day</time_frame>
    <description>Assessment of Blood Pressure (mmHg) in both closed and open suction systems.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Mechanical Ventilation</condition>
  <arm_group>
    <arm_group_label>Closed suction system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in mechanical ventilation were aspirated with closed suction system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open suction system</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in mechanical ventilation were aspirated with open suction system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Closed suction system</intervention_name>
    <description>In mechanically ventilated patients, intratracheal secretions were aspirated with closed suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with open suction system.</description>
    <arm_group_label>Closed suction system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open suction system</intervention_name>
    <description>In mechanically ventilated patients, intratracheal secretions were aspirated with open suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with closed suction system.</description>
    <arm_group_label>Open suction system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over 18 years old;&#xD;
&#xD;
          -  intubated with a 7.5mm endotracheal tube;&#xD;
&#xD;
          -  mechanically ventilated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  upper gastrointestinal bleeding;&#xD;
&#xD;
          -  hemodynamic instability;&#xD;
&#xD;
          -  airway bleeding;&#xD;
&#xD;
          -  previous lung diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodrigo D Raimundo, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculdade de Medicina do ABC</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Talita Dias da Silva</investigator_full_name>
    <investigator_title>Ph.D.</investigator_title>
  </responsible_party>
  <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/NCT03256214
org study id: 467
nct id: NCT03256214
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Seventy-one patients in intensive care were randomized for initial treatment with open
      suction systems or closed suction systems in a cross-over design. Pulmonary and
      cardiovascular physiology was assessed immediately before and after three 10-second
      aspirations per suction. Were analyzed the effect of each suction system on physiologic
      parameters while adjusting for their respective values prior to suction.
Study Participants. The sample consisted of 71 subjects, both genders, hospitalized in
      intensive care units. This study protocol was approved by the Research Ethics Committee of
      Heliopolis Hospital - Sao Paulo - Brazil.

      Patients were randomized in the following way: patients hospitalized in the odd beds of ICU
      were aspirated initially by open suction system (OSS) and later by the closed suction system
      (CSS); patients hospitalized in the even beds were aspirated by CSS, initially, and
      subsequently by the OSS.

      Cardiopulmonary measures: Eligible patients were evaluated for the presence or absence of
      neural stimulation to spontaneous ventilation (drive breathing). If the patients showed
      spontaneous respiratory movements, they were sedated to the level four of Ramsay scale. After
      this initial evaluation, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean
      blood pressure (MBP), heart rate (HR), respiratory rate (RR), oxygen saturation (SAT), tidal
      volume (Vt), peak pressure (Ppeak), plateau pressure (Pplat), positive end expiratory
      pressure (PEEP), and inspiratory flow (V) were measured. The HR and SAT data were collected
      by visualization of DX 2010 multiparameter monitor from Dixtal. SBP, DBP and MBP were
      obtained by a single measurement provided by the same monitor. Data of peak pressure, plateau
      pressure, positive end expiratory pressure, inspiratory flow and tidal volume were used to
      calculate compliance (C) and airway resistance (R). Data were collected before and after
      tracheal aspiration.

      Pulmonary Suction: After the initial data were obtained, patients who were under
      volume-controlled ventilation mode (VCV) were submitted to the first aspiration procedure
      according to randomization described above. Patients who were under pressure-controlled
      ventilation mode (PCV) were changed to VCV mode, respecting the individual mean tidal volume,
      which means that the tidal volume of the patient under PCV would be used to ventilate in VCV.
      All patients were ventilated with a Savina (Drager) mechanical ventilator. Aspiration
      procedures and data collection were done by a health care professional unaware of the study
      regimes or objectives. After the measurement of the initial parameters, patients underwent
      the procedure of aspiration in an open or closed system according to the randomization
      described above. All patients were aspirated by a system that had not been used previously.
      The procedure was timed and required 10 seconds to insert and remove the aspiration catheter,
      with each aspiration performed three times. The outside diameter of the aspiration catheter
      had half the inner diameter of the endotracheal tube, and the negative pressure was adjusted
      between 70 and 100 mmHg. At the end of the aspiration procedure, physiological assessments
      were repeated. Patients were returned to nursing care and underwent the second procedure
      after six hours from initial aspiration.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Improvements in Pulmonary parameters when comparing closed and open suction systems.
time frame: 1 day
description: Assessment of Peak Pressure (cmH20) in both closed and open suction systems.
measure: Improvements in Cardiovascular parameters when comparing Closed and open suction systems.
time frame: 1 day
description: Assessment of Blood Pressure (mmHg) in both closed and open suction systems.
arm group label: Closed suction system
arm group type: Experimental
description: Patients in mechanical ventilation were aspirated with closed suction system.
arm group label: Open suction system
arm group type: Active Comparator
description: Patients in mechanical ventilation were aspirated with open suction system.
intervention type: Procedure
intervention name: Closed suction system
description: In mechanically ventilated patients, intratracheal secretions were aspirated with closed suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with open suction system.
arm group label: Closed suction system
intervention type: Procedure
intervention name: Open suction system
description: In mechanically ventilated patients, intratracheal secretions were aspirated with open suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with closed suction system.
arm group label: Open suction system
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Rodrigo D Raimundo, Ph.D.
role: Principal Investigator
affiliation: Faculdade de Medicina do ABC
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Talita Dias da Silva
investigator title: Ph.D.
sharing ipd: Undecided