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

July 11, 2014 updated by: 5i Sciences, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: active cNEP @ -45cmw
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)

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: no intervention
Routine care is administered without the application of cNEP.

What is the study measuring?

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
Time Frame: 1 hour
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.
Time Frame: 1 hour
1 hour
The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.
Time Frame: 1 hour
1 hour
The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group.
Time Frame: 1 hour
interventions such as reduction of sedative medication or jaw thrust.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

5i Sciences, Inc.

Investigators

  • Principal Investigator: Walter Coyle, M.D., Scripps Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

March 29, 2013

First Submitted That Met QC Criteria

July 5, 2013

First Posted (ESTIMATE)

July 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2014

Last Update Submitted That Met QC Criteria

July 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5iS-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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