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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colonoscopy, Oxygenation, Ventilation

Intervention / Treatment
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* Device: Oxygen via nasal cannula
* Device: Oxygen via SuperNO2VA nasal mask


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxygen via nasal cannula (Standard of Care)<br>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<br>* Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.<br>|
| Experimental: Oxygen via SuperNO2VA nasal mask<br>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<br>* 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.<br>|

What is the study measuring?
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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) |