NCT01895062

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 6, 2014

Completed
Last Updated

August 6, 2014

Status Verified

July 1, 2014

Enrollment Period

1 year

First QC Date

March 29, 2013

Results QC Date

March 4, 2014

Last Update Submit

July 11, 2014

Conditions

Airway ObstructionApneaHypopnea

Keywords

colonoscopyoxygen desaturation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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.

    1 hour

Study Arms (2)

active cNEP @ -45cmw

EXPERIMENTAL

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)

no intervention

NO INTERVENTION

Routine care is administered without the application of cNEP.

Interventions

Airway Management System (AMS)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.

active cNEP @ -45cmw

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Green Clinic

La Jolla, California, 92037, United States

Location

Related Publications (1)

  • Kais SS, Klein KB, Rose RM, Endemann S, Coyle WJ. Continuous negative external pressure (cNEP) reduces respiratory impairment during screening colonoscopy: a pilot study. Endoscopy. 2016 Jun;48(6):584-7. doi: 10.1055/s-0042-102533. Epub 2016 Apr 25.

    PMID: 27110692DERIVED

MeSH Terms

Conditions

Airway ObstructionApnea

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Richard Rose
Organization
5i Sciences
rrose@5isciences.com
858-759-2205

Study Officials

  • Walter Coyle, M.D.

    Scripps Healthcare

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2013

First Posted

July 10, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 6, 2014

Results First Posted

August 6, 2014

Record last verified: 2014-07

Locations

US(1)