CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 174 enrolled
Drug / intervention
Oxygen via nasal cannula +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03139448
NCT03139448N/ACompleted

Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy: a Prospective Randomized Trial

Vanderbilt University Medical Center·interventional·Posted May 4, 2017·Updated Feb 5, 2019

In Brief

A clinical study evaluating Oxygen via nasal cannula and Oxygen via SuperNO2VA nasal mask for Colonoscopy and 2 related conditions. Completed, enrolled 174 participants across 1 site.

Detailed Summary

Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also proven to be more effective than combined oral-nasal ventilation during induction of general anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for oxygenation and ventilation in patients undergoing colonoscopy. The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and standard care with nasal cannula.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 4, 2017
Enrollment StartMay 17, 2017
Primary CompletionOct 6, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.2 years ago

Interventions

Oxygen via nasal cannuladevice

Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.

Oxygen via SuperNO2VA nasal maskdevice

The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.