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Completed

NCT Number: NCT02859597

Use of High Flow Nasal Cannula During Sedation of Morbidly Obese Patients in the Endoscopy Suite

This study evaluates the ability of high flow nasal cannula versus nasal cannula to oxygenate morbidly obese patients undergoing moderate to deep sedation for gastrointestinal procedures.

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Key information

Conditions

Morbid Obesity Body Weight Deep Sedation Noninvasive Ventilation Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

The respiratory physiology of morbidly obese patients is altered due to restriction of the chest wall motion which decreases pulmonary compliance. In addition, anatomical changes lead to an increased incidence of airway obstruction in morbidly obese patients during periods of sedation. Both a typical nasal cannula and high flow nasal cannula provide supplemental oxygen to the patients to prevent desaturation and hypoxia. However, the higher flow rates of high flow nasal cannulas are able to produce allows for washout of carbon dioxide from the respiratory system aiding with ventilation and creates 3 to 5 cm H2O of positive end expiration pressure which helps prevent collapse of the airway aiding with oxygenation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index greater than or equal to 40
  • Scheduled for a gastrointestinal endoscopy that requires MAC sedation

Exclusion criteria

  • Body Mass Index less than 40
  • Pregnant
  • Require either invasive or non-invasive ventilation for respiratory failure
  • Use home oxygen
  • Ventilation is via a tracheostomy
  • The procedure is emergent

Treatment and study plan

High Flow Nasal Cannula

Device

High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.

Nasal Cannula

Device

Control group will receive oxygen via standard flow nasal cannula at 5 liters per minute (approximately an FiO2 of 0.35)

Primary outcomes

  1. Ability to Maintain Oxygenation

    Time frame: During the period of sedation, on average up to 1 hour

    The ease at which the Anesthesiologist is able to maintain adequate oxygenation during the period of sedation required for the procedure. the ability of each oxygen device to maintain oxygenation was based on the number of manipulations; more manipulations, the device is less effective at maintaining saturation for this population.

Secondary outcomes

  1. Number of Participants Requiring Airway Adjuncts During Procedure

    Time frame: During the period of sedation, on average up to 1 hour

    The use of airway adjuncts such as oral and nasal airways to insure adequate oxygenation during procedure.

  2. Number of Participants Who Need an Increase in Fraction of Inspired Oxygen

    Time frame: During period of sedation, on average up to 1 hour

    Need to increase the FiO2 to maintain adequate oxygenation

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Randomized. Controlled Trial of the Utilization of High Flow Nasal Cannula for Oxygenation of Sedated Morbidly Obese Patients in the Endoscopy Suite

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2016
Registry last updated
Apr 16, 2020

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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