Supplemental Oxygen and Oxygen Desaturations in Colonoscopies

Summary

This study will compare apnea and oxygen desaturation events among various methods of supplemental oxygen delivery during procedural sedation in colonoscopy patients. The goals of the study are to track apnea (10 or more seconds without respiration) and oxygen desaturation (hemoglobin oxygen saturation less than 90%) events in colonoscopy patients receiving one of three different methods of supplemental oxygen administration. The first method is standard-of-care continuous flow oxygen therapy, where a constant flow of oxygen is administered through a nasal cannula or oxygen mask. The second method is synchronized flow oxygen therapy. This is a delivery method implemented in an FDA-cleared medical device (Sovant, Dynasthetics LLC) which delivers variable-volume oxygen pulses only as the patient inhales. The delivered oxygen pulses are commensurate to the set flow rate and the patient's respiratory rate. The third method is continuous positive airway pressure therapy (CPAP), where non-invasive pressure support is given to the patient's airway to help keep their airway open. The hypothesis being tested is that synchronized flow delivery and CPAP therapy will demonstrate reductions in apnea and oxygen desaturation events compared to traditional continuous flow oxygen therapy.

Conditions

• Oxygen Desaturation
• Apnea (Central and Obstructive)
• Airway Obstruction

Interventions

DEVICE

Breath-synchronized oxygen

This is breath-synchronized oxygen delivery of supplemental oxygen by the FDA-cleared Sovant device, where oxygen is given synchronously with the patient's inhalation only through a nasal cannula or non-rebreather oxygen mask.

DEVICE

CPAP

Supplemental oxygen delivered via continuous positive airway pressure (CPAP) therapy through a tight-fitting mask over the patient's mouth and nose, where oxygen flow rate is automatically adjusted by the investigational devce to maintain the anesthetist-selected airway pressure.

DEVICE

Control

This is the traditional approach of administering oxygen at a constant flow rate chosen by the anesthetist through a nasal cannula or non-rebreather oxygen mask.

Sponsors & Collaborators

• University of Utah

  lead OTHER

Principal Investigators

• Kai Kuck, PhD · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-18

Primary Completion

2026-10-31

Completion

2026-12-31

FDA Device

Yes

Countries

• United States

Study Locations