N/A
N=174
Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy
Colonoscopy · Oxygenation · Ventilation
Bottom Line
View on ClinicalTrials.gov: NCT03139448 ↗Enrolled (actual)
174
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Time to First Intervention — 10; 19 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oxygen via nasal cannula (Device); Oxygen via SuperNO2VA nasal mask (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Intervention |
10; 19 | — |
| SECONDARY Number of Subjects Receiving Interventions for Airway Management |
46; 14 | — |
| SECONDARY Duration of Intervention |
19; 12 | — |
| SECONDARY Oxygen Saturation Reading- Median |
100.0; 100; 98; 100; 99; 100 | — |
| SECONDARY Oxygen Saturation- Lowest Reading |
99.11; 99.23; 96.22; 99.31; 97.57; 99.39 | — |
| SECONDARY Number of Participants With Oxygen Saturation- Reading Below 90% |
16; 3 | — |
| SECONDARY Tidal Volume (VT) |
1032.80; 1011.39; 527.01; 625.31; 533.26; 589.22 | — |
| SECONDARY Respiratory Rate (RR) |
15.07; 15.36; 15.15; 15.21; 17.77; 16.95 | — |
| SECONDARY Minute Ventilation (MV) |
14.29; 14.52; 8.41; 9.16; 8.82; 9.62 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03139448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.