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

Study Overview
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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.

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

Conditions
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Apnea, Airway Obstruction, Hypopnea

Intervention / Treatment
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* Device: Airway Management System (AMS)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active cNEP @ -45cmw<br>cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source. | Device: Airway Management System (AMS)<br>* 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.<br>|
| No Intervention: no intervention<br>Routine care is administered without the application of cNEP. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RI Events in the cNEP Group Compared to the no cNEP Group, Where RI is Defined as Either: i Oxygen Saturation < 90% or ii. Apneas/Hypopneas of > 15 Sec Duration i. Oxygen Saturation <90% ii. Presence of Apneas or Hypopneas | Mean RI events in the no cNEP group was 3.5 compared to 1.92 in the cNEP group (p=0.022) | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Safety of cNEP as Determined by Adverse Events Reported by the Investigators. |  | 1 hour | 
| The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group. |  | 1 hour | 
| The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group. | interventions such as reduction of sedative medication or jaw thrust. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, oxygen desaturation