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



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 80
Updated:5/5/2014
Start Date:March 2013
Contact:Sarah Endemann, Ms, CCRC
Email:Endemann.Sarah@scrippshealth.org
Phone:858-554-5255

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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
We found this trial at
1
site
Scripps Green Clinic
La Jolla, California 92037
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mi
from
La Jolla, CA
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