N/A N=63 Randomized Treatment

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

Desaturation of Blood · Obesity · Colonoscopy · Sleep Apnea · High Flow Nasal Cannula

Bottom Line

View on ClinicalTrials.gov: NCT03148262 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: The Number of Desaturation Episodes — 0; 0 Episodes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: The Comfort Flo system (Device); The Salter nasal cannula (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Desaturation Episodes	0; 0	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Age between 18-80
Subjects undergoing colonoscopies
Morbidly obese BMI ≥ 40

Exclusion Criteria

Subjects deemed hemodynamically unstable by the anesthesia team
Subjects who are an aspiration risk and will require endotracheal intubation.
Pregnancy
Subjects with an allergy to propofol
Patients who are unable to tolerate the high flow nasal cannula secondary to discomfort
Subjects unwilling to sign consent
Chronic obstructive pulmonary disease
Patients that received medications other than lidocaine and propofol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03148262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.