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

5i Sciences

Status and phase

Completed

Phase 2

Phase 1

Conditions

Apnea

Hypopnea

Airway Obstruction

Treatments

Device: Airway Management System (AMS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01895062

5iS-009

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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