Supplemental Oxygen and Oxygen Desaturations in Colonoscopies

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Breath-synchronized oxygen — DEVICE
  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.
• CPAP — DEVICE
  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.
• Control — DEVICE
  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.

Study Details

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.

Key Dates

Start date

May 18, 2026

Status verified

Mar 2026

Primary completion

Oct 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

280 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Continuous Oxygen Flow
  This arm is the traditional supplemental oxygen delivery of providing a continuous oxygen flow through a nasal cannula or non-rebreather oxygen mask at a flow rate set by the anesthetist.
• Experimental: Synchronized Oxygen Flow
  This arm is breath-synchronized oxygen delivery with the FDA-cleared Sovant oxygen delivery device through a nasal cannula or non-rebreather mask. Oxygen is pulsed at the beginning of the patient's inhalation and flow is discontinued the rest of the breath.
• Experimental: CPAP
  This arm is oxygen delivery through continuous positive airway pressure (CPAP) therapy administered by an investigational device, where oxygen is given through a tight-fitting mask over the patient's mouth and nose. The oxygen flow rate is automatically adjusted by the device to maintain a set pressure in the patient's airway as selected by the anesthetist.

Primary Outcome Measure

Oxygen Saturation AUC [ Time Frame: The duration of the procedure ]

Central Contacts

• Kai Kuck, PhD
  (801) 581-6393
  [email protected]
• Trey S Blackwell, MS
  (801) 395-4038
  [email protected]

Locations (1)

Find similar trials in South Jordan, UT

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