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Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center

NCT05754255 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-02-24

No results posted yet for this study

Summary

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.

Conditions

  • Colonoscopy
  • Positive-Pressure Respiration

Interventions

DEVICE

Nasal Cannula

A nasal cannula is a medical device to provide supplemental oxygen therapy to people who have lower oxygen levels. There are two types of nasal cannulas: low flow and high flow. The device has two prongs and sits below the nose. The two prongs deliver oxygen directly into your nostrils.

DEVICE

Nasal Positive Airway Pressure System

Positive airway pressure (PAP) treatment uses a machine to pump air under pressure into the airway of the lungs. This helps keep the windpipe open during sleep. The forced air delivered by CPAP (continuous positive airway pressure) prevents episodes of airway collapse that block the breathing in people with obstructive sleep apnea and other breathing problems.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • John DeWitt, MD · Professor of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-06-01
Completion
2024-06-03
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 NCT05754255 on ClinicalTrials.gov