Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center
Withdrawn before enrolling · Not applicable
Conditions studied: Colonoscopy, Positive-Pressure Respiration
In brief
The primary objective of the prospective study is to compare the incidence, duration, and severity of oxygen desaturation in high-risk patients randomized to nasal mask with nasal positive airway pressure (PAP) or standard care (nasal cannula) receiving propofol sedation during colonoscopy in an ambulatory surgical center (ASC). Patients will be randomized in groups of ten to one of two groups using a random number table. Group A: standard care with a nasal cannula. Group B: SuperNO2VA™EtCO2. Following the procedure subjects will be asked to complete satisfaction surveys before leaving the ASC and 48 +/- hours following their procedure. Researchers will compare levels of satisfaction and levels of oxygen saturation.
Key facts
- Study ID
- NCT05754255
- Run by
- Indiana University
- People needed
- 0
- Starts
- 2023-09-01
- Expected to finish
- 2024-06-03
- Last updated by the study team
- 2026-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- Outpatients undergoing colonoscopy.
- American Society of Anesthesiology (ASA) Physical Status I-III
- BMI ≥35 kg/m2, documented obstructive sleep apnea or BMI>30 with STOP-BANG score ≥3
- Written informed consent
You may not qualify if…
- Inpatient status
- Active Congestive Heart Failure Exacerbation
- Untreated ischemic heart disease
- Acute exacerbation of respiratory disorders, including 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
- History of allergic reaction to polypropylene or PVC.
- Tracheostomy
- Supra-glottic or sub-glottic tumor
- Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
- Known obstructing colon tumor, lesion, or stricture
- Previous colon surgery (excluding anal surgery)
- Active GI bleeding (hematochezia or melena during procedure preparation)
- Large polyp (> 2cm) removal
- Previous failed or unsuccessfully completed colonoscopy.
Where it is running
- Indiana University — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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