<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/NCT03807375</url>
  </required_header>
  <id_info>
    <org_study_id>preoxygenation</org_study_id>
    <nct_id>NCT03807375</nct_id>
  </id_info>
  <brief_title>The Comparison of the Methods Applied in Bariatric Surgery in Terms of Preoxygenation Time</brief_title>
  <official_title>Evaluation of the Effect of CPAP and Mask Ventilation on Preoxygenation Time in Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Diskapi Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Diskapi Training and Research Hospital</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 aim of the study was to evaluate the preoxygenation time by observing patients undergoing&#xD;
      preoxygenation with CPAP (Continuous Positive Airway Pressure) and Mask Ventilation in the&#xD;
      clinic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Criteria for inclusion in the study:&#xD;
&#xD;
      Planned elective bariatric surgery under general anesthesia ASA 1-2 class Between 20-50 years&#xD;
      50 patients&#xD;
&#xD;
        1. Group: Patients undergoing CPAP (Continuous Positive Airway Pressure) during&#xD;
           preoxygenation will be included.&#xD;
&#xD;
        2. Group: Patients undergoing preoxygenation without CPAP will be included&#xD;
&#xD;
      In both groups, the time from the anesthesia device to the endtidal O2 90% and the endtidal&#xD;
      CO2 value in this order will be recorded.&#xD;
&#xD;
      Heart rate, blood pressure, endtidal O2 and CO2 values will be recorded during preoxygenation&#xD;
      and after intubation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevention of desaturation during intubation</measure>
    <time_frame>5 minutes</time_frame>
    <description>Prevent desaturation of the apnea period during endotracheal intubation in bariatric surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>prevention of side effects of hypoxia</measure>
    <time_frame>10 minutes</time_frame>
    <description>hypoxia-induced arrhythmia hypotension tachycardia</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Time to Reach 90% Endtidal Oxygen During Preoxygenation</condition>
  <arm_group>
    <arm_group_label>CPAP</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O. The process will continue until the end-tidal O2 concentration ≥ 90% is removed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard preoxygenation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>During the preoxygenation, the ventilator device will be put in spontaneous mode and the procedure will continue until the End-tidal O2 concentration ≥90% is removed without additional pressure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CPAP preoxygenation</intervention_name>
    <description>During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O.</description>
    <arm_group_label>CPAP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria:&#xD;
&#xD;
               1. Patients between the ages of 20 and 50 years&#xD;
&#xD;
               2. American Society of Anesthesiologists I, II or III&#xD;
&#xD;
               3. Patients with body mass index of 40 and over&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. cardiopulmonary disease&#xD;
&#xD;
          2. patients with previous abdominal or thoracic surgery or cerebrovascular disease&#xD;
&#xD;
          3. story of intracranial hypertension or epilepsy&#xD;
&#xD;
          4. patients with a story of difficult tracheal intubation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Diskapi Yildirim Beyazit Training Research Hospital</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Bouroche G, Bourgain JL. Preoxygenation and general anesthesia: a review. Minerva Anestesiol. 2015 Aug;81(8):910-20. Epub 2015 Jun 5.</citation>
    <PMID>26044934</PMID>
  </reference>
  <results_reference>
    <citation>Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.</citation>
    <PMID>28099321</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara Diskapi Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>ilkay baran akkuş</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <keyword>CPAP(Continuous Positive Airway Pressure)</keyword>
  <keyword>Standard preoxygenation</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03807375
org study id: preoxygenation
nct id: NCT03807375
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study was to evaluate the preoxygenation time by observing patients undergoing
      preoxygenation with CPAP (Continuous Positive Airway Pressure) and Mask Ventilation in the
      clinic.
Criteria for inclusion in the study:

      Planned elective bariatric surgery under general anesthesia ASA 1-2 class Between 20-50 years
      50 patients

        1. Group: Patients undergoing CPAP (Continuous Positive Airway Pressure) during
           preoxygenation will be included.

        2. Group: Patients undergoing preoxygenation without CPAP will be included

      In both groups, the time from the anesthesia device to the endtidal O2 90% and the endtidal
      CO2 value in this order will be recorded.

      Heart rate, blood pressure, endtidal O2 and CO2 values will be recorded during preoxygenation
      and after intubation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Prevention of desaturation during intubation
time frame: 5 minutes
description: Prevent desaturation of the apnea period during endotracheal intubation in bariatric surgery
measure: prevention of side effects of hypoxia
time frame: 10 minutes
description: hypoxia-induced arrhythmia hypotension tachycardia
arm group label: CPAP
arm group type: Other
description: During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O. The process will continue until the end-tidal O2 concentration ≥ 90% is removed.
arm group label: standard preoxygenation
arm group type: No Intervention
description: During the preoxygenation, the ventilator device will be put in spontaneous mode and the procedure will continue until the End-tidal O2 concentration ≥90% is removed without additional pressure.
intervention type: Other
intervention name: CPAP preoxygenation
description: During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O.
arm group label: CPAP
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Bouroche G, Bourgain JL. Preoxygenation and general anesthesia: a review. Minerva Anestesiol. 2015 Aug;81(8):910-20. Epub 2015 Jun 5.
PMID: 26044934
citation: Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.
PMID: 28099321
responsible party type: Principal Investigator
investigator affiliation: Ankara Diskapi Training and Research Hospital
investigator full name: ilkay baran akkuş
investigator title: principle investigator
sharing ipd: No