Supplemental Oxygen and Oxygen Desaturations in Colonoscopies

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About 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.

Eligibility criteria

Qualifiers

Adult patient

No life threatening conditions

Undergoing colonoscopy procedures and receiving procedural sedation at the University of Utah Health clinic in South Jordan, Utah.

Disqualifiers

Inability/refusal of subject to provide informed consent.

Less than 18 years of age.

Standard colonoscopy exclusion criteria used at the GI lab at the University of Utah.

Patients known or suspected to be pregnant.

Trial design

Treatments tested in this trial

  • Breath-synchronized oxygen
  • CPAP
  • Control

Treatment groups

280 Participants
are divided into 3 treatment groups

Sponsors and collaborators