Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction

The University of Texas System (UT)

Status

Completed

Conditions

Obstructive Sleep Apnea, Obesity

Treatments

Device: SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)

Device: Standard care with a facemask.

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05524220

HSC-MS-22-0351

Details and patient eligibility

About

The purpose of this study is to to compare oxygenation and ventilation on spontaneously ventilating obese patients or those with diagnosed or undiagnosed Obstructive sleep apnea (OSA) undergoing day colonoscopy under Propofol based sedation, between the SuperNO2VA Et™ nasal positive airway pressure (PAP) device and routine care with face mask for oxygen (O2).

Enrollment

139 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients undergoing colonoscopy
American Society of Anesthesiology (ASA) Physical Status I-III
BMI ≥30 kg/m2 or suspected Obstructive Sleep Apnea

Exclusion criteria

Inpatient status
Active Congestive Heart Failure Exacerbation
Untreated ischemic heart disease
Acute exacerbation of respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma
Emergent procedures
Pregnancy
Previous enrollment in this study
Inability to provide informed consent
Additional medical testing planned for the same day
History of allergic reaction to Propofol
Tracheostomy
Supra-glottic or sub-glottic tumor
Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
Prisoners
Unable to fit SuperNoVa