<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/NCT02968706</url>
  </required_header>
  <id_info>
    <org_study_id>2016-516</org_study_id>
    <nct_id>NCT02968706</nct_id>
  </id_info>
  <brief_title>HFNC Versus Conventional Nasal Cannula in Oxygen Performance in Patients Receiving Colonoscopy Under IV Sedation</brief_title>
  <acronym>HFNC</acronym>
  <official_title>High Flow Nasal Cannula Versus Conventional Nasal Cannula in Oxygen Performance in Patients Receiving Colonoscopy Under Intravenous Sedation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aventura Hospital and Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aventura Hospital and Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate if high flow nasal cannula (HFNC), as compared to&#xD;
      conventional nasal cannula, improves oxygenation and prevents desaturation events in obese&#xD;
      patients undergoing colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intravenous sedation during colonoscopy has become the standard practice in United States&#xD;
      given its higher patient satisfaction and procedural quality. The most common used short&#xD;
      acting sedative agent is propofol. Although possessing safe and rapidly reversed&#xD;
      pharmacokinetic properties, propofol intravenous infusion can lead to respiratory depression&#xD;
      and hypoxemia. In one prospective study, hypoxemia events, defined by oxygen saturation less&#xD;
      than 90 percent was found in 20 percent of patients receiving colonoscopy using propofol&#xD;
      sedation. The mechanism of hypoxemia is mainly hypoventilation, airway collapse, and carbon&#xD;
      dioxide (CO2) retention. When it comes to gastrointestinal procedures, using oxygen devices&#xD;
      for augmenting ventilation is usually avoided, ex: positive pressure ventilation, since it&#xD;
      can lead to bowel distention and affect quality of procedures. Therefore most hospitals in&#xD;
      United States still use nasal cannula of oxygen therapy during gastrointestinal procedures,&#xD;
      and there is lack of available options of oxygen therapy which can improve hypoventilation&#xD;
      and prevent hypoxemia.&#xD;
&#xD;
      High flow nasal cannula (HFNC) is a new generation of oxygen therapy. It provides constant&#xD;
      high flow oxygen delivery with heated and humidified air. Moreover, it has been studied that&#xD;
      high velocity of airflow can create the effect of &quot;positive end expiratory pressure&quot; thus&#xD;
      assist ventilation and work of breathing. Compared to conventional nasal cannula and face&#xD;
      mask, HFNC has demonstrated superior performance in oxygenation, work of breathing and&#xD;
      patient comfort in many studies. Since its invention, HFNC has been studied in post-cardiac&#xD;
      surgery, post-extubation, bronchoscopy and dental procedures and all of them show equal to&#xD;
      better oxygen performance in comparison of nasal cannula.&#xD;
&#xD;
      While capnographic monitoring has been studied to prevent hypoxemia during sedation, no&#xD;
      studies have been done to evaluate the clinical utility of new generation oxygen therapy.&#xD;
      Obesity is associated with increased frequency of sedation related complications especially&#xD;
      hypoxemia during propofol mediated sedation for advanced endoscopic procedures. The&#xD;
      Investigators hypothesized that HFNC may improve oxygen performance compared to conventional&#xD;
      nasal cannula for obese patients receiving colonoscopy under intravenous sedation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rate of desaturation events during procedures (desaturation events are defined by either SpO2 drops more than 5% compared to baseline SpO2 OR SpO2&lt;90% at any time of procedures)</measure>
    <time_frame>Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence rate of carbon dioxide retention (end tidal CO2 more than 50 mmHg at any time of procedure)</measure>
    <time_frame>Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients satisfaction level (patient comfort and mouth dryness assessed by a questionnaire with 4-scale questions)</measure>
    <time_frame>One time point (15 minutes after the patient recovered from anesthesia sedation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory rates before and after colonoscopy procedure, and highest respiratory rate during colonoscopy procedure.</measure>
    <time_frame>Three time points (Before, through out, and within 5 minutes after the colonoscopy procedure)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence rate of hypoxia rescue intervention events (e.g. jaw lift, anterior mandibular shifting, head elevation )</measure>
    <time_frame>Through out the colonoscopy procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Desaturation of Blood</condition>
  <arm_group>
    <arm_group_label>High flow cannula arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the experimental arm (the high flow nasal cannula group) will receive heated humidified high flow oxygen of 50L/min at FiO2 of 40% throughout the colonoscopy. A patient satisfaction survey will be administered after procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional cannula arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in control arm (the conventional nasal cannula group) will receive an oxygen flow of 2-5 L /min. A patient satisfaction survey will be administered after procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High Flow Nasal Cannula</intervention_name>
    <description>Heated humidified high flow oxygen of 50 L/min at FiO2 of 40%</description>
    <arm_group_label>High flow cannula arm</arm_group_label>
    <other_name>High flow oxygen delivering device (OPTIFLO)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional Nasal Cannula</intervention_name>
    <description>Supplemental oxygen of 2-5 L/min</description>
    <arm_group_label>Conventional cannula arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient satisfaction questionnaire</intervention_name>
    <description>Questionnaire</description>
    <arm_group_label>Conventional cannula arm</arm_group_label>
    <arm_group_label>High flow cannula arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ≥ 30.&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  ASA classification II and III.&#xD;
&#xD;
          -  Scheduled for colonoscopy.&#xD;
&#xD;
          -  Able to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to propofol and any of its contents.&#xD;
&#xD;
          -  Baseline SpO2 less than 93%.&#xD;
&#xD;
          -  Patients who require intubation for airway protection based on anesthesiologist&#xD;
             discretion.&#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_official>
    <last_name>Hilda Mahmoudi, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aventura Hospital and Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hilda Mahmoudi, MD, MPH</last_name>
    <phone>(305) 682 7261</phone>
    <email>Hilda.Mahmoudi@hcahealthcare.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aventura Hospital and Medical Center</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hilda Mahmoudi, MD, MPH</last_name>
      <phone>305-682-7261</phone>
      <email>Hilda.mahmoudi@hcahealthcare.com</email>
    </contact>
    <contact_backup>
      <last_name>Jestin Pudussery Kattalan, MD</last_name>
      <email>Jestin.PudusseryKattalan@hcahealthcare.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>February 17, 2017</last_update_submitted>
  <last_update_submitted_qc>February 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>High Flow Nasal Cannula</keyword>
  <keyword>Colonoscopy</keyword>
  <keyword>Obesity</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/NCT02968706
org study id: 2016-516
nct id: NCT02968706
lead sponsor: 
has dmc: No
The purpose of this study is to investigate if high flow nasal cannula (HFNC), as compared to
      conventional nasal cannula, improves oxygenation and prevents desaturation events in obese
      patients undergoing colonoscopy.
Intravenous sedation during colonoscopy has become the standard practice in United States
      given its higher patient satisfaction and procedural quality. The most common used short
      acting sedative agent is propofol. Although possessing safe and rapidly reversed
      pharmacokinetic properties, propofol intravenous infusion can lead to respiratory depression
      and hypoxemia. In one prospective study, hypoxemia events, defined by oxygen saturation less
      than 90 percent was found in 20 percent of patients receiving colonoscopy using propofol
      sedation. The mechanism of hypoxemia is mainly hypoventilation, airway collapse, and carbon
      dioxide (CO2) retention. When it comes to gastrointestinal procedures, using oxygen devices
      for augmenting ventilation is usually avoided, ex: positive pressure ventilation, since it
      can lead to bowel distention and affect quality of procedures. Therefore most hospitals in
      United States still use nasal cannula of oxygen therapy during gastrointestinal procedures,
      and there is lack of available options of oxygen therapy which can improve hypoventilation
      and prevent hypoxemia.

      High flow nasal cannula (HFNC) is a new generation of oxygen therapy. It provides constant
      high flow oxygen delivery with heated and humidified air. Moreover, it has been studied that
      high velocity of airflow can create the effect of "positive end expiratory pressure" thus
      assist ventilation and work of breathing. Compared to conventional nasal cannula and face
      mask, HFNC has demonstrated superior performance in oxygenation, work of breathing and
      patient comfort in many studies. Since its invention, HFNC has been studied in post-cardiac
      surgery, post-extubation, bronchoscopy and dental procedures and all of them show equal to
      better oxygen performance in comparison of nasal cannula.

      While capnographic monitoring has been studied to prevent hypoxemia during sedation, no
      studies have been done to evaluate the clinical utility of new generation oxygen therapy.
      Obesity is associated with increased frequency of sedation related complications especially
      hypoxemia during propofol mediated sedation for advanced endoscopic procedures. The
      Investigators hypothesized that HFNC may improve oxygen performance compared to conventional
      nasal cannula for obese patients receiving colonoscopy under intravenous sedation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Incidence rate of desaturation events during procedures (desaturation events are defined by either SpO2 drops more than 5% compared to baseline SpO2 OR SpO2<90% at any time of procedures)
time frame: Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy)
measure: Incidence rate of carbon dioxide retention (end tidal CO2 more than 50 mmHg at any time of procedure)
time frame: Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy)
measure: Patients satisfaction level (patient comfort and mouth dryness assessed by a questionnaire with 4-scale questions)
time frame: One time point (15 minutes after the patient recovered from anesthesia sedation)
measure: Respiratory rates before and after colonoscopy procedure, and highest respiratory rate during colonoscopy procedure.
time frame: Three time points (Before, through out, and within 5 minutes after the colonoscopy procedure)
measure: Incidence rate of hypoxia rescue intervention events (e.g. jaw lift, anterior mandibular shifting, head elevation )
time frame: Through out the colonoscopy procedure
arm group label: High flow cannula arm
arm group type: Experimental
description: Patients in the experimental arm (the high flow nasal cannula group) will receive heated humidified high flow oxygen of 50L/min at FiO2 of 40% throughout the colonoscopy. A patient satisfaction survey will be administered after procedure.
arm group label: Conventional cannula arm
arm group type: Active Comparator
description: Participants in control arm (the conventional nasal cannula group) will receive an oxygen flow of 2-5 L /min. A patient satisfaction survey will be administered after procedure.
intervention type: Device
intervention name: High Flow Nasal Cannula
description: Heated humidified high flow oxygen of 50 L/min at FiO2 of 40%
arm group label: High flow cannula arm
other name: High flow oxygen delivering device (OPTIFLO)
intervention type: Device
intervention name: Conventional Nasal Cannula
description: Supplemental oxygen of 2-5 L/min
arm group label: Conventional cannula arm
intervention type: Other
intervention name: Patient satisfaction questionnaire
description: Questionnaire
arm group label: Conventional cannula arm
arm group label: High flow cannula arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hilda Mahmoudi, MD, MPH
role: Principal Investigator
affiliation: Aventura Hospital and Medical Center
last name: Hilda Mahmoudi, MD, MPH
phone: (305) 682 7261
email: Hilda.Mahmoudi@hcahealthcare.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
sharing ipd: No