Phase 2
Completed N=54
Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy
Airway Obstruction · Apnea · Hypopnea
Source: ClinicalTrials.gov NCT01895062 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.