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

NCT05754255 | Withdrawn FDA Device

• 1 other identifier: 17675
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Incidence of desaturation

  Compare incidence of desaturation of Nasal PAP Versus Nasal Administration of Oxygen

  60 minutes

• Duration of oxygen desaturation

  Compare the duration of desaturation of Nasal PAP Versus Nasal Administration of Oxygen

  60 minutes

• Severity of oxygen desaturation

  Compare the severity of desaturation of Nasal PAP Versus Nasal Administration of Oxygen

  60 minutes

Secondary Outcomes (21)

• Total Amount of Propofol for Adequate Sedation

  60 minutes

• Modified Observer's Assessment of Alertness/Sedation Scale

  60 minutes

• Endoscope Insertion

  60 minutes

• Incidence of Airway maneuvers

  60 minutes

• Duration of Airway maneuvers

  60 minutes

Study Arms (2)

Group A: standard care with a nasal cannula.

ACTIVE COMPARATOR

Group A will be given the standard nasal cannula during sedation. The cannula prongs will be inserted into the patient's nose to provide oxygen to the patient.

Device: Nasal Cannula

Group B: SuperNO2VA™EtCO2

ACTIVE COMPARATOR

Group B will be given a nasal oxygen to deliver gas, create a seal, and provide positive pressure. The mask will be placed over a patient's nose and connected to either an anesthesia circuit or hyperinflation bag during respiratory, anesthesia, and resuscitation procedures.

Device: Nasal Positive Airway Pressure System

Interventions

Nasal Cannula DEVICE

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.

Group A: standard care with a nasal cannula.

Nasal Positive Airway Pressure System DEVICE

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.

Also known as: Nasal CPAP

Group B: SuperNO2VA™EtCO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Cannula

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• John DeWitt, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 31, 2022
• First Posted: March 3, 2023
• Study Start: September 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 3, 2024
• Last Updated: February 24, 2026

Record last verified: 2024-07

Locations

US (1)