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High-flow Nasal Oxygenation in Obese Patients During Apnea

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ClinicalTrials.gov Identifier: NCT03195504
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
David Wong, University Health Network, Toronto

Brief Summary:
Before going off to sleep patients are given oxygen to saturate blood with oxygen to extend time before a decrease in the level of oxygen in the blood occurs. During this period, obese patients have a faster decrease in the level of oxygen in their blood. This study uses a device called "high-flow nasal cannula" (HFNC), which delivers humidified high-flow oxygen through 2 small plastic tubes placed just inside nostrils. In the intensive care unit settings this device has been used extensively and has become a standard practice. Purpose of this study is to determine whether these high-flow nasal cannula increase the time safely when going to sleep during elective surgery.

Condition or disease Intervention/treatment Phase
Apneic Oxygenation High-flow Nasal Cannulae Bariatric Surgery Anesthesia Induction Device: HFNC Device: CON (control) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Consented patients will be randomly assigned either to the interventional group (High Flow Nasal Cannula- HFNC) or to the control group (CON). The Group HFNC will be preoxygenated using HFNC and the Group CON will receive standard preoxygenation.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of Apneic Oxygenation Using High-flow Nasal Cannula in Morbidly Obese Patients Undergoing General Anesthesia
Actual Study Start Date : August 10, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Arm Intervention/treatment
Experimental: HFNC (High Flow Nasal Cannulae)
High Flow Nasal Cannulae providing humidified, high-flow oxygen during induction of anesthesia
Device: HFNC
High flow nasal oxygen (60 l) under GA

Active Comparator: CON (control)
Standard flow oxygen during induction of anesthesia
Device: CON (control)
Standard oxygen (10-15 l) under GA




Primary Outcome Measures :
  1. Measurement of safe apnea time [ Time Frame: Maximum up to 6 minutes ]
    Safe apnea time, defined by time to desaturation (SpO2 > 95%) or apnea maximum up to 6 minutes


Secondary Outcome Measures :
  1. Highest EtCO2 [ Time Frame: Every minute up to 5 minutes on commencing ventilation ]
    Highest EtCO2 on commencing ventilation

  2. Lowest SpO2 [ Time Frame: Every minute up to 5 minutes after intubation ]
    Lowest SpO2 during intubation procedure

  3. Time to regain baseline SpO2 [ Time Frame: Up to 5 minutes after intubation ]
    Time to regain baseline SpO2 after intubation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age more than18 years old
  • ASA status I-III
  • Elective surgery performed under general anesthesia requiring endotracheal intubation
  • BMI more than 40 kg/m2

Exclusion Criteria:

  • Chronic respiratory disease
  • SpO2 <98% after supplementing oxygen
  • Previous or anticipated difficult intubation
  • Uncontrolled hypertension
  • Ischemic heart disease
  • Congestive heart failure
  • Increased intracranial pressure
  • Uncontrolled GERD
  • Known allergy or contraindication to anesthesia drugs
  • Nasal blockade contraindicating the use of HFNC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195504


Locations
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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto

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Responsible Party: David Wong, Professor Anesthesia (MD), University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03195504     History of Changes
Other Study ID Numbers: 16-6264.0
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs