Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy
1 other identifier
interventional
174
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedStudy Start
First participant enrolled
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2017
CompletedResults Posted
Study results publicly available
February 5, 2019
CompletedFebruary 5, 2019
February 1, 2019
5 months
May 1, 2017
January 9, 2019
February 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Time to First Intervention
The time period between the beginning of standard of care propofol bolus and/or start of propofol infusion to time of initiation of the first intervention for airway management.
Usually 5 minutes
Secondary Outcomes (8)
Number of Subjects Receiving Interventions for Airway Management
Duration of colonoscopy procedure (usually 30 minutes)
Duration of Intervention
Duration of colonoscopy procedure (usually 30 minutes)
Oxygen Saturation Reading- Median
Duration of colonoscopy procedure (usually 30 minutes)
Oxygen Saturation- Lowest Reading
Duration of colonoscopy procedure (usually 30 minutes)
Number of Participants With Oxygen Saturation- Reading Below 90%
Duration of colonoscopy procedure (usually 30 minutes)
- +3 more secondary outcomes
Study Arms (2)
Oxygen via nasal cannula (Standard of Care)
ACTIVE COMPARATORThe anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center.
Oxygen via SuperNO2VA nasal mask
EXPERIMENTALThe 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.
Interventions
Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.
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.
Eligibility Criteria
You may qualify if:
- Patients 18 years or older
- BMI of 30-50
- ASA 1-3 Scheduled for colonoscopy with sedation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Related Publications (1)
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.
PMID: 31313720DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Koffi Kla, MD
- Organization
- Vanderbilt University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Koffi M Kla, M.D.
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 1, 2017
First Posted
May 4, 2017
Study Start
May 17, 2017
Primary Completion
October 6, 2017
Study Completion
October 6, 2017
Last Updated
February 5, 2019
Results First Posted
February 5, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share