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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139448
• Other study ID #: 170488
• Status: Completed
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: October 6, 2017

Study information

• Verified date: February 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: October 6, 2017
• Est. primary completion date: October 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy
• Oxygenation
• Ventilation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Revolutionary Medical Devices, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Duration of Intervention	Duration of intervention	Duration of colonoscopy procedure (usually 30 minutes)
Secondary	Oxygen Saturation Reading- Median	Oxygen saturation reading- Median	Duration of colonoscopy procedure (usually 30 minutes)
Secondary	Oxygen Saturation- Lowest Reading	Oxygen saturation- Lowest reading	Duration of colonoscopy procedure (usually 30 minutes)
Secondary	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)
Secondary	Tidal Volume (VT)	Tidal volume (VT) defined as the volume of air displaced between inhalation and exhalation.	Duration of colonoscopy procedure (usually 30 minutes)
Secondary	Respiratory Rate (RR)	Respiratory Rate (RR)	Duration of colonoscopy procedure (usually 30 minutes)
Secondary	Minute Ventilation (MV)	Minute ventilation (MV)	Duration of colonoscopy procedure (usually 30 minutes)