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The Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients

NCT03479905 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2024-08-13

Study results available
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Summary

It is standard practice in the United States and many parts of world to perform Gastrointestinal endoscopy with the patient under deep intravenous sedation. Obesity is accepted as a patient specific risk factor for hypoxic events during procedural sedation for GI endoscopic procedures. The obese population has a higher prevalence of obstructive sleep apnea (OSA), which is characterized by repeated obstruction of the upper airway, and leads to apnea and desaturation. This prospective, randomized study was designed to compare the effectiveness of the high flow nasal cannula, standard nasal cannula and standard face mask in morbidly obese patients with a high risk of sleep apnea, (BMI greater than 40, STOPBANG greater or equal to 5) receiving deep intravenous sedation during colonoscopies. This study will assess which method leads to a lower incidence of intraoperative desaturation events compared to the current standard of care.

Conditions

  • Desaturation of Blood
  • Colonoscopy

Interventions

OTHER

Salter nasal cannula

Oxygen will be delivered via standard nasal cannula during colonoscopy

OTHER

Face mask

Oxygen will be delivered via face mask during colonoscopy

DEVICE

High Flow Nasal Cannula

A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Christina Riccio, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2020-01-07
Completion
2023-09-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03479905 on ClinicalTrials.gov