Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy

Colonoscopy has become an essential part of the patient management, especially in the field
of colorectal cancer prevention. About 15 million colonoscopies were done in the United
States in 2012. Data from United States and European countries suggest that the majority of
investigations are performed with the aid of sedation. Since sedation can cause significant
respiratory depression, resulting in hypoxia, especially in obese and elder populations who
are more likely to undergo colonoscopy, usually oxygen is provided to patients via a nasal
cannula to minimize the risk of hypoxia.

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.

Inclusion Criteria:

- Patients 18 years or older

- BMI of 30-50

- ASA 1-3 Scheduled for colonoscopy with sedation

Exclusion Criteria:

- Untreated ischemic heart disease

- Acute and chronic respiratory disorders, including COPD and asthma

- Emergent procedures

- Planned use of an invasive airway (ie: supra-glottic device, LMA, etc)

- Pregnant women

- Nasal or oral disease resulting in difficulty of either nasal breathing or mouth
breathing

- Patient refusal