<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/NCT03028688</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00071111</org_study_id>
    <nct_id>NCT03028688</nct_id>
  </id_info>
  <brief_title>HIFLO ENDO-High Flow Nasal Cannula in GI Endoscopy</brief_title>
  <official_title>HIFLO ENDO- Use of High Flow Nasal Cannula Oxygenation to Increase Patient Safety During Upper GI Endoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Anesthesia Patient Safety Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Millions of patients undergo upper GI endoscopy in the United States each year. A large&#xD;
      number of these patients have anesthesia to assist with their comfort during the procedure.&#xD;
      The majority of patients do not have a protected airway during the procedure, meaning there&#xD;
      is no endotracheal tube. Instead the current standard of care is to give supplementary oxygen&#xD;
      via nasal cannula. Because patients are deeply sedated or have general anesthesia there is a&#xD;
      risk for low oxygen saturation during the procedure, which presents a significant patient&#xD;
      safety issue. The purpose of the clinical trial is compare the current anesthesia standard of&#xD;
      care against high flow nasal cannula oxygen delivery during anesthesia. The investigator's&#xD;
      hypothesis is that high flow nasal cannula oxygen delivery will decrease the frequency with&#xD;
      which patients experience hypoxemia during anesthesia for upper GI endoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 21, 2017</start_date>
  <completion_date type="Actual">May 9, 2019</completion_date>
  <primary_completion_date type="Actual">May 9, 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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hypoxemia event (Low blood oxygen level)</measure>
    <time_frame>The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.</time_frame>
    <description>The primary outcome measure will be occurrence of a low blood oxygen level defined by oxygen saturation less than 92% for greater than 15 seconds at any point during the patient's anesthesia. This will be a dichotomous outcome variable analyzed by time to event.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypercarbia event (Elevated blood CO2 level)</measure>
    <time_frame>The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.</time_frame>
    <description>The secondary outcome measure will be occurrence of an elevated blood carbon dioxide level defined as 20 mmHg above the patient's baseline value at any time during their anesthesia. This will be a dichotomous outcome variable analyzed by time to event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypotension event (Low blood pressure)</measure>
    <time_frame>The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.</time_frame>
    <description>The secondary outcome measure will occurrence of low blood pressure defined as blood pressure 25% below baseline value any time during the patient's anesthesia. This will be a dichotomous outcome variable analyzed by time to event.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">262</enrollment>
  <condition>Anesthesia Morbidity</condition>
  <arm_group>
    <arm_group_label>Current standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the current standard of care will receive the usual anesthesia care for upper GI endoscopy. In addition participants will have transcutaneous PCO2 measurements performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High flow nasal cannula group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen and will also have transcutaneous PCO2 measurements performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High flow nasal cannula oxygen</intervention_name>
    <description>Participants will receive high flow nasal cannula oxygen delivery during anesthesia. Participants will also have transcutaneous PCO2 measurements performed using a cutaneous electrode.</description>
    <arm_group_label>High flow nasal cannula group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Having Upper GI endoscopy expected to last greater than 15 minutes with anesthesia.&#xD;
&#xD;
          2. Age greater than or equal to 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Propofol, midazolam, or fentanyl allergy&#xD;
&#xD;
          2. Pre-procedure plan for general anesthesia with an endotracheal tube (at the discretion&#xD;
             of the attending anesthesiologist)&#xD;
&#xD;
          3. Any procedure with planned electro-cautery as a high-inspired oxygen concentration&#xD;
             could increase the risk for airway or esophageal fire.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael A Mazzeffi, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Michael Mazzeffi</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <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/NCT03028688
org study id: HP-00071111
nct id: NCT03028688
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Millions of patients undergo upper GI endoscopy in the United States each year. A large
      number of these patients have anesthesia to assist with their comfort during the procedure.
      The majority of patients do not have a protected airway during the procedure, meaning there
      is no endotracheal tube. Instead the current standard of care is to give supplementary oxygen
      via nasal cannula. Because patients are deeply sedated or have general anesthesia there is a
      risk for low oxygen saturation during the procedure, which presents a significant patient
      safety issue. The purpose of the clinical trial is compare the current anesthesia standard of
      care against high flow nasal cannula oxygen delivery during anesthesia. The investigator's
      hypothesis is that high flow nasal cannula oxygen delivery will decrease the frequency with
      which patients experience hypoxemia during anesthesia for upper GI endoscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Hypoxemia event (Low blood oxygen level)
time frame: The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.
description: The primary outcome measure will be occurrence of a low blood oxygen level defined by oxygen saturation less than 92% for greater than 15 seconds at any point during the patient's anesthesia. This will be a dichotomous outcome variable analyzed by time to event.
measure: Hypercarbia event (Elevated blood CO2 level)
time frame: The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.
description: The secondary outcome measure will be occurrence of an elevated blood carbon dioxide level defined as 20 mmHg above the patient's baseline value at any time during their anesthesia. This will be a dichotomous outcome variable analyzed by time to event.
measure: Hypotension event (Low blood pressure)
time frame: The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.
description: The secondary outcome measure will occurrence of low blood pressure defined as blood pressure 25% below baseline value any time during the patient's anesthesia. This will be a dichotomous outcome variable analyzed by time to event.
arm group label: Current standard of care
arm group type: No Intervention
description: Participants in the current standard of care will receive the usual anesthesia care for upper GI endoscopy. In addition participants will have transcutaneous PCO2 measurements performed.
arm group label: High flow nasal cannula group
arm group type: Experimental
description: Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen and will also have transcutaneous PCO2 measurements performed.
intervention type: Device
intervention name: High flow nasal cannula oxygen
description: Participants will receive high flow nasal cannula oxygen delivery during anesthesia. Participants will also have transcutaneous PCO2 measurements performed using a cutaneous electrode.
arm group label: High flow nasal cannula group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael A Mazzeffi, MD MPH
role: Principal Investigator
affiliation: University of Maryland School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Michael Mazzeffi
investigator title: Assistant Professor of Anesthesiology
sharing ipd: No