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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Airway Obstruction Apnea Hypopnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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active cNEP @ -45cmw

cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.

Group Type EXPERIMENTAL

Airway Management System (AMS)

Intervention Type DEVICE

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.

no intervention

Routine care is administered without the application of cNEP.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No