Clinical trial NCT03139448: Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy
Official title: Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Oxygenation
Ventilation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Revolutionary Medical Devices, Inc.
First posted: 2017-05-04
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to First Intervention
timeFrame: Usually 5 minutes
Secondary outcomes:
measure: Number of Subjects Receiving Interventions for Airway Management
timeFrame: Duration of colonoscopy procedure (usually 30 minutes)
measure: Duration of Intervention
timeFrame: Duration of colonoscopy procedure (usually 30 minutes)
measure: Oxygen Saturation Reading- Median
timeFrame: Duration of colonoscopy procedure (usually 30 minutes)
measure: Oxygen Saturation- Lowest Reading
timeFrame: Duration of colonoscopy procedure (usually 30 minutes)
measure: Number of Participants With Oxygen Saturation- Reading Below 90%
timeFrame: Duration of colonoscopy procedure (usually 30 minutes)
measure: Tidal Volume (VT)
timeFrame: Duration of colonoscopy procedure (usually 30 minutes)
measure: Respiratory Rate (RR)
timeFrame: Duration of colonoscopy procedure (usually 30 minutes)
measure: Minute Ventilation (MV)
timeFrame: Duration of colonoscopy procedure (usually 30 minutes)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Koffi M Kla, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bai Y, Xu Z, Chandrashekar M, St Jacques PJ, Liang Y, Jiang Y, Kla K. Comparison of a simplified nasal continuous positive airways pressure device with nasal cannula in obese patients undergoing colonoscopy during deep sedation: A randomised clinical trial. Eur J Anaesthesiol. 2019 Sep;36(9):633-640. doi: 10.1097/EJA.0000000000001052.