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

Last updated: February 1, 2019
Sponsor: Vanderbilt University Medical Center
Overall Status: Completed

Phase

N/A

Condition

Colon Cancer Screening

Treatment

N/A

Clinical Study ID

NCT03139448
170488
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 18 years or older

  • BMI of 30-50

  • ASA 1-3 Scheduled for colonoscopy with sedation

Exclusion

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 mouthbreathing

  • Patient refusal

Study Design

Total Participants: 174
Study Start date:
May 17, 2017
Estimated Completion Date:
October 06, 2017

Study 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.

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

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