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

Completed · Phase 1/Phase 2

Conditions studied: Airway Obstruction, Apnea, Hypopnea

In brief

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.

Key facts

Study ID

NCT01895062

Run by

5i Sciences, Inc.

People needed

54

Starts

2013-03-01

Expected to finish

2014-03-01

Last updated by the study team

2014-08-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects undergoing elective colonoscopy at the Study Site who have fewer than three or more than three positive responses on the STOP BANG questionnaire

You may not qualify if…

• Presence of severe cardiopulmonary or neurologic disease as determined by the investigator
• History of vascular fragility associated with cutaneous pressure
• History of hypersensitivity to silicone
• Inability to properly fit cNEP collar to the subject
• The presence of excessive facial hair in the region where the cNEP collar is positioned
• Known carotid vascular disease, previous major neck surgery or radiation therapy to the cervical region
• Presence of anatomical abnormalities in the neck or pharyngeal region (such as enlarged tonsils)
• Inability to provide informed consent

Where it is running

• Scripps Green Clinic — La Jolla, California, United States

Full record on ClinicalTrials.gov

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