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

Primary Purpose

Airway Obstruction, Apnea, Hypopnea

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Airway Management System (AMS)
Sponsored by
5i Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Airway Obstruction focused on measuring colonoscopy, oxygen desaturation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Green Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

active cNEP @ -45cmw

no intervention

Arm Description

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

Routine care is administered without the application of cNEP.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

The Safety of cNEP as Determined by Adverse Events Reported by the Investigators.
The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.
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.

Full Information

First Posted
March 29, 2013
Last Updated
July 11, 2014
Sponsor
5i Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01895062
Brief Title
Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy
Official Title
Effectiveness and Safety of Continuous Negative External Pressure (cNEP) in Preventing Sedation-Related Respiratory Impairment in Adults Undergoing Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
5i Sciences, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction, Apnea, Hypopnea
Keywords
colonoscopy, oxygen desaturation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active cNEP @ -45cmw
Arm Type
Experimental
Arm Description
cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.
Arm Title
no intervention
Arm Type
No Intervention
Arm Description
Routine care is administered without the application of cNEP.
Intervention Type
Device
Intervention Name(s)
Airway Management System (AMS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
Mean RI events in the no cNEP group was 3.5 compared to 1.92 in the cNEP group (p=0.022)
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
The Safety of cNEP as Determined by Adverse Events Reported by the Investigators.
Time Frame
1 hour
Title
The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.
Time Frame
1 hour
Title
The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group.
Description
interventions such as reduction of sedative medication or jaw thrust.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Coyle, M.D.
Organizational Affiliation
Scripps Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Green Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27110692
Citation
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.
Results Reference
derived

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

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