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

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

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 Overview

• Status: Completed
• Conditions: Ventilation; Colonoscopy; Oxygenation
• Intervention / Treatment: Device: Oxygen via nasal cannula; Device: Oxygen via SuperNO2VA nasal mask

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.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oxygen via nasal cannula (Standard of Care); The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center.	Device: Oxygen via nasal cannula; Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.
Experimental: Oxygen via SuperNO2VA nasal mask; 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.	Device: Oxygen via SuperNO2VA nasal mask; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Receiving Interventions for Airway Management	Number of subjects receiving interventions for airway management including chin up and/or jaw thrust, oral and/or nasal airway insertion, mask ventilation, intubation with endotracheal tube (ETT) or laryngeal mask airway (LMA) insertion	Duration of colonoscopy procedure (usually 30 minutes)
Duration of Intervention	Duration of intervention	Duration of colonoscopy procedure (usually 30 minutes)
Oxygen Saturation Reading- Median	Oxygen saturation reading- Median	Duration of colonoscopy procedure (usually 30 minutes)
Oxygen Saturation- Lowest Reading	Oxygen saturation- Lowest reading	Duration of colonoscopy procedure (usually 30 minutes)
Number of Participants With Oxygen Saturation- Reading Below 90%	Number of participants with oxygen saturation- reading below 90%	Duration of colonoscopy procedure (usually 30 minutes)
Tidal Volume (VT)	Tidal volume (VT) defined as the volume of air displaced between inhalation and exhalation.	Duration of colonoscopy procedure (usually 30 minutes)
Respiratory Rate (RR)	Respiratory Rate (RR)	Duration of colonoscopy procedure (usually 30 minutes)
Minute Ventilation (MV)	Minute ventilation (MV)	Duration of colonoscopy procedure (usually 30 minutes)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Revolutionary Medical Devices, Inc.
• Investigators: Principal Investigator: Koffi M Kla, M.D., Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): October 6, 2017
• Study Completion (Actual): October 6, 2017

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 170488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No