Supplemental Oxygen for Apnea During Colonoscopy
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Kai Kuck, PhD
Principal Investigator
University of Utah
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive supplemental oxygen using one of three methods: continuous flow, synchronized flow, or CPAP therapy during colonoscopy procedures
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Breath-synchronized oxygen
- CPAP
- Supplemental Oxygen
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
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