Effectiveness and Safety of Continuous Negative External Pressure (cNEP) in Preventing Sedation-Related Respiratory Impairment in Adults Undergoing Colonoscopy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
active cNEP @ -45cmw
cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.
Intervention: Airway Management System (AMS) (Device)
no intervention
Routine care is administered without the application of cNEP.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- 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)