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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

280 Participants
are divided into 3 treatment groups
Group A: Continuous Oxygen FlowActive comparator 1 intervention
Group B: Synchronized Oxygen FlowExperimental treatment 1 intervention
Group C: CPAPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Oxygen Saturation AUC

The area under the hemoglobin oxygen saturation curve (AUC) will be calculated as the difference between the desaturation threshold of 90% and the recorded SpO2 integrated over the duration that SpO2 was below the 90% threshold.

Time frame
The duration of the procedure

Secondary outcomes

1

Apneic events

The number and duration of apneic events, with apnea defined as 10 seconds or more without respiration.

Time frame
The duration of the procedure

Other outcomes

Sponsors and contacts

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