<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/NCT02216006</url>
  </required_header>
  <id_info>
    <org_study_id>Dnr 2012/335</org_study_id>
    <nct_id>NCT02216006</nct_id>
  </id_info>
  <brief_title>High Fresh Gas Flow After Intubation</brief_title>
  <official_title>High Fresh Gas Flow After Intubation - A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Västmanland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Västmanland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atelectasis is common during and after general anesthesia. Atelectasis develops early if&#xD;
      preoxygenation with 100% oxygen is used and continuously used during induction until&#xD;
      endotracheal intubation. The investigators hypothesize that a rapid anti-preoxygenation&#xD;
      maneuver immediately after confirming a successful intubation, reduces the area of&#xD;
      atelectasis as investigated by computed tomography compared to a standard procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Atelectasis</measure>
    <time_frame>Within 1-2 hours, just before emergence from anesthesia</time_frame>
    <description>The area of atelectasis in the lungs is assessed by computed tomography (CT) 10 mm above the dome of the right diaphragm and expressed in cm2 and as % of the total lung area in the particular scan.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arterial blood gases</measure>
    <time_frame>Within 2-3 hours perioperatively</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Atelectasis</condition>
  <arm_group>
    <arm_group_label>Control group, conventional ventilatory settings</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Handling of the airway during induction and intubation is performed in a conventional manner.&#xD;
Initial ventilatory settings are also done in a conventional manner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High fresh gas flow, high minute ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Handling of the airway during induction and intubation is performed in a conventional manner.&#xD;
Immediately after confirming a successful intubation the effect of preoxygenation is eliminated with an anti-preoxygenation maneuver.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control group, conventional ventilatory settings</intervention_name>
    <description>Handling of the airway during induction and intubation is performed in a conventional manner.&#xD;
Initial ventilatory settings are also done in a conventional manner. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI &gt;25) and a respiratory frequency of 10. The fresh gas flow is set to 1 Liter per minute with an oxygen mixture of 40%, aiming for an inspired FiO2 of 30-35%.&#xD;
Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.</description>
    <arm_group_label>Control group, conventional ventilatory settings</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>High fresh gas flow, high minute ventilation</intervention_name>
    <description>Handling of the airway during induction and intubation is performed in a conventional manner.&#xD;
Immediately after confirming a successful intubation, the effect of preoxygenation is eliminated with a fresh gas flow of 10 L/min of air, delivered with volume controlled ventilation consisting of tidal volumes of approximately 15 ml/kg ideal body weight, a positive expiratory pressure of 10 cm H20 and a respiratory frequency of 10. As soon as the end tidal O2 reaches 25%, the ventilator settings are adjusted to normal values (same as in the control group), i.e. tidal volume 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI &gt;25). The mixture of oxygen in the fresh gas is increased to 40% and the fresh gas flow is set to 1 Liter per minute, aiming for an inspired FiO2 of 30-35%.&#xD;
Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.</description>
    <arm_group_label>High fresh gas flow, high minute ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy patients, American Society of Anesthesiology (ASA) I-II&#xD;
&#xD;
          -  Patients scheduled for orthopaedic day case surgery in general anaesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA class III or higher&#xD;
&#xD;
          -  Body Mass Index (BMI) 30 or higher&#xD;
&#xD;
          -  Arterial oxygen saturation (SpO2) &lt;94% breathing air&#xD;
&#xD;
          -  Chronic Obstructive Pulmonary Disease (COPD)&#xD;
&#xD;
          -  Ischemic heart disease&#xD;
&#xD;
          -  Haemoglobin &lt;100g/L&#xD;
&#xD;
          -  Known or anticipated difficult airway and/or intubation&#xD;
&#xD;
          -  Active smokers and ex-smokers with a history of more than 6 pack years&#xD;
&#xD;
          -  Need for interscalene or supraclavicular regional anaesthesia with risk of phrenic&#xD;
             nerve paralysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mats Enlund, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Landstinget i Värmland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Landstinget Västmanland</name>
      <address>
        <city>Köping</city>
        <state>Västmanland</state>
        <zip>731 30</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>May 12, 2015</last_update_submitted>
  <last_update_submitted_qc>May 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Västmanland</investigator_affiliation>
    <investigator_full_name>Erland Ostberg</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Atelectasis</keyword>
  <keyword>Fresh gas flow</keyword>
  <keyword>Prevention</keyword>
  <keyword>Oxygenation</keyword>
  <keyword>Anaesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Atelectasis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02216006
org study id: Dnr 2012/335
nct id: NCT02216006
lead sponsor: 
has dmc: No
Atelectasis is common during and after general anesthesia. Atelectasis develops early if
      preoxygenation with 100% oxygen is used and continuously used during induction until
      endotracheal intubation. The investigators hypothesize that a rapid anti-preoxygenation
      maneuver immediately after confirming a successful intubation, reduces the area of
      atelectasis as investigated by computed tomography compared to a standard procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Atelectasis
time frame: Within 1-2 hours, just before emergence from anesthesia
description: The area of atelectasis in the lungs is assessed by computed tomography (CT) 10 mm above the dome of the right diaphragm and expressed in cm2 and as % of the total lung area in the particular scan.
measure: Arterial blood gases
time frame: Within 2-3 hours perioperatively
arm group label: Control group, conventional ventilatory settings
arm group type: Active Comparator
description: Handling of the airway during induction and intubation is performed in a conventional manner.
Initial ventilatory settings are also done in a conventional manner.
arm group label: High fresh gas flow, high minute ventilation
arm group type: Active Comparator
description: Handling of the airway during induction and intubation is performed in a conventional manner.
Immediately after confirming a successful intubation the effect of preoxygenation is eliminated with an anti-preoxygenation maneuver.
intervention type: Procedure
intervention name: Control group, conventional ventilatory settings
description: Handling of the airway during induction and intubation is performed in a conventional manner.
Initial ventilatory settings are also done in a conventional manner. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI >25) and a respiratory frequency of 10. The fresh gas flow is set to 1 Liter per minute with an oxygen mixture of 40%, aiming for an inspired FiO2 of 30-35%.
Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.
arm group label: Control group, conventional ventilatory settings
intervention type: Procedure
intervention name: High fresh gas flow, high minute ventilation
description: Handling of the airway during induction and intubation is performed in a conventional manner.
Immediately after confirming a successful intubation, the effect of preoxygenation is eliminated with a fresh gas flow of 10 L/min of air, delivered with volume controlled ventilation consisting of tidal volumes of approximately 15 ml/kg ideal body weight, a positive expiratory pressure of 10 cm H20 and a respiratory frequency of 10. As soon as the end tidal O2 reaches 25%, the ventilator settings are adjusted to normal values (same as in the control group), i.e. tidal volume 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI >25). The mixture of oxygen in the fresh gas is increased to 40% and the fresh gas flow is set to 1 Liter per minute, aiming for an inspired FiO2 of 30-35%.
Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.
arm group label: High fresh gas flow, high minute ventilation
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mats Enlund, MD, PhD
role: Study Chair
affiliation: Landstinget i Värmland
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Region Västmanland
investigator full name: Erland Ostberg
investigator title: M.D.
mesh term: Pulmonary Atelectasis