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OpenTrials
Completed

NCT Number: NCT03195504

High-flow Nasal Oxygenation in Obese Patients During Apnea

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.

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Key information

Conditions

Apneic Oxygenation Anesthesia Induction Bariatric Surgery High-flow Nasal Cannulae

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HFNC

Device

High flow nasal oxygen (60 l) under GA

CON (control)

Device

Standard oxygen (10-15 l) under GA

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Effectiveness of Apneic Oxygenation Using High-flow Nasal Cannula in Morbidly Obese Patients Undergoing General Anesthesia

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 22, 2017
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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