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

Not Applicable

Completed

• Conditions: Colonoscopy; Ventilation; Oxygenation
• Interventions: Device: Oxygen via SuperNO2VA nasal mask; Device: Oxygen via nasal cannula

• Registration Number: NCT03139448
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-01
• Study First Posted: 2017-05-04
• Study Start: 2017-05-17
• Primary Completion: 2017-10-06
• Study Completion: 2017-10-06
• Results First Submitted: 2019-01-09
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-01
• Last Update Submitted: 2019-02-01
• Results First Posted: 2019-02-05
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Patients 18 years or older
• BMI of 30-50
• ASA 1-3 Scheduled for colonoscopy with sedation

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxygen via SuperNO2VA nasal mask	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.
Oxygen via nasal cannula (Standard of Care)	Oxygen via nasal cannula	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center.

Primary Outcome Measures

Name	Time	Method
Time to First Intervention	Usually 5 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Respiratory Rate (RR)	Duration of colonoscopy procedure (usually 30 minutes)	Respiratory Rate (RR)
Duration of Intervention	Duration of colonoscopy procedure (usually 30 minutes)	Duration of intervention
Oxygen Saturation Reading- Median	Duration of colonoscopy procedure (usually 30 minutes)	Oxygen saturation reading- Median
Number of Participants With Oxygen Saturation- Reading Below 90%	Duration of colonoscopy procedure (usually 30 minutes)	Number of participants with oxygen saturation- reading below 90%
Oxygen Saturation- Lowest Reading	Duration of colonoscopy procedure (usually 30 minutes)	Oxygen saturation- Lowest reading
Number of Subjects Receiving Interventions for Airway Management	Duration of colonoscopy procedure (usually 30 minutes)	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
Tidal Volume (VT)	Duration of colonoscopy procedure (usually 30 minutes)	Tidal volume (VT) defined as the volume of air displaced between inhalation and exhalation.
Minute Ventilation (MV)	Duration of colonoscopy procedure (usually 30 minutes)	Minute ventilation (MV)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States