Evaluation of Oxygen Desaturation and Apnea Events With Supplemental Oxygen During Procedural Sedation in Colonoscopies
University of Utah
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.
Description
Sedation procedures such as colonoscopies involve administering drugs to patients that reduce awareness and pain without complete loss of consciousness. A side effect of these drugs is respiratory depression, where the patient's breathing becomes more shallow and less frequent. Another side effect is partial or complete obstruction of the airway by the airway tissue, inhibiting the flow of oxygen to the lungs. When a patient experiences significant respiratory depression or airway obstruction, they may not receive adequate oxygen, which may result in low hemoglobin oxygen saturation (SpO2), wh…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Adult patient * No life threatening conditions * Undergoing colonoscopy procedures and receiving procedural sedation at the University of Utah Health clinic in South Jordan, Utah. Exclusion Criteria: * 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. * Patients with an ASA physical status of IV (A patient with severe systemic disease that is a constant threat to life) or V (A moribund patient who is…
Interventions
- DeviceBreath-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.
- DeviceCPAP
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.
- DeviceControl
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.
Location
- University of Utah South Jordan Health Center - EndoscopySouth Jordan, Utah