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

5

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

54 participants in 2 patient groups

active cNEP @ -45cmw
Experimental group
Description:
cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.
Treatment:
Device: Airway Management System (AMS)
no intervention
No Intervention group
Description:
Routine care is administered without the application of cNEP.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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