NCT01895062

Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy

Effectiveness and Safety of Continuous Negative External Pressure (cNEP) in Preventing Sedation-Related Respiratory Impairment in Adults Undergoing Colonoscopy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: 5i Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of this study is to determine the effectiveness and safety of delivering continuous negative external pressure (cNEP) to the upper airway as a means of preventing episodes of respiratory impairment (RI) such as hypoxemia, apnea and hypoventilation associated with the use of intravenous sedation in elective colonoscopy in adult patients.

Conditions

• Airway Obstruction
• Apnea
• Hypopnea

Interventions

Type	Name	Description
DEVICE	Airway Management System (AMS)	The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck. The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-07-10
• Last updated: 2014-08-06
• Results posted: 2014-08-06

Locations

1 site across 1 country: United States