NCT03148262

High-Flow Nasal Cannula and Desaturation Episodes in the Morbidly Obese Patients

Completed NA Results posted Last updated 19 November 2018

What this trial tests

NA trial testing The Comfort Flo system in Desaturation of Blood in 59 participants. Completed in 22 January 2018.

Timeline

10 May 2017

Primary endpoint
28 August 2017

22 January 2018

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	59
Start date	10 May 2017
Primary completion	28 August 2017
Estimated completion	22 January 2018
Sites	2 locations across United States

Drugs / interventions tested

• The Comfort Flo system
• The Salter nasal cannula

Conditions studied

• Desaturation of Blood — all drugs for Desaturation of Blood →
• Obesity — all drugs for Obesity →
• Colonoscopy — all drugs for Colonoscopy →
• Sleep Apnea — all drugs for Sleep Apnea →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 80, any sex, with Desaturation of Blood or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Desaturation Episodes Primary · Perioperative period during colonoscopy

The number of desaturation episodes defined as blood oxygen saturation (SpO2) below 90% during the perioperative period during colonoscopy.

Group	Value	95% CI
The High Flow Nasal Cannula	0	0 – 1
The Standard Nasal Cannula	0	0 – 2

Sponsor's own description

It is standard practice in the United States and many parts of world to perform Gastrointestinal (GI) endoscopy with the patient under deep 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 and the standard nasal cannula in morbidly obese (BMI \> 40) patients receiving deep intravenous sedation during colonoscopies. This study will assess whether use of the high flow nasal cannula (HFNC) leads to less intraoperative desaturation events compared to the current standard of care.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. High-flow versus standard nasal cannula in morbidly obese patients during colonoscopy: A prospective, randomized clinical trial.
   Riccio CA, Sarmiento S, Minhajuddin A, Nasir D, et al · · 2019 · cited 78× · PMID 30391445 · DOI 10.1016/j.jclinane.2018.10.026
2. The effectiveness of high-flow nasal cannula during sedated digestive endoscopy: a systematic review and meta-analysis.
   Zhang YX, He XX, Chen YP, Yang S. · · 2022 · cited 26× · PMID 35209948 · DOI 10.1186/s40001-022-00661-8