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

Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895062
• Other study ID #: 5iS-009
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 29, 2013
• Last updated: July 11, 2014
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: 5i Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Airway Obstruction
• Apnea
• Hypopnea

Intervention

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.

Locations

Country	Name	City	State
United States	Scripps Green Clinic	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
5i Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The Safety of cNEP as Determined by Adverse Events Reported by the Investigators.		1 hour	Yes
Secondary	The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.		1 hour	Yes
Secondary	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	Yes