Phase 2
N=54
Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy
Airway Obstruction · Apnea · Hypopnea
Bottom Line
View on ClinicalTrials.gov: NCT01895062 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: 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 — 1.92; 3.5 RI events — p=<0.022
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Airway Management System (AMS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- 5i Sciences, Inc.
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
1.92; 3.5 | <0.022 sig |
| SECONDARY The Safety of cNEP as Determined by Adverse Events Reported by the Investigators. |
— | — |
| SECONDARY The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group. |
— | — |
| SECONDARY The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group. |
1; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01895062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.