A Phase 1/2 interventional study of Airway Management System (AMS) in Airway Obstruction, Apnea and Hypopnea, sponsored by 5i Sciences, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-08-06.
Sponsored by 5i Sciences, Inc. · Phase 1/2, Interventional, and Prevention
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.
154 studies on the registry are indexed under Airway Obstruction; 30 are open to participants now.
This study's enrollment of 54 is close to the median of 56 across 92 interventional studies indexed under Airway Obstruction.
Browse Airway Obstruction studies →This is the only study on the registry with 5i Sciences, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.
Device: Airway Management System (AMS)
Routine care is administered without the application of cNEP.
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.
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)
Time frame: 1 hour
The Safety of cNEP as Determined by Adverse Events Reported by the Investigators.
Time frame: 1 hour
The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.
Time frame: 1 hour
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.
Time frame: 1 hour
| Milestone | Active cNEP @ -45cmw | no Intervention |
|---|---|---|
| Started | 30 | 24 |
| Completed | 30 | 24 |
| Not completed | 0 | 0 |
Mean RI events in the no cNEP group was 3.5 compared to 1.92 in the cNEP group (p=0.022)
| RI events | Active cNEP @ -45cmw | no Intervention |
|---|---|---|
| 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 (1.1 to 2.75) | 3.5 (2.37 to 4.64) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
interventions such as reduction of sedative medication or jaw thrust.
| interventions to restore airway | Active cNEP @ -45cmw | no Intervention |
|---|---|---|
| The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group. | 1 | 0 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active cNEP @ -45cmw | — | 0/30 (0%) | 0/30 (0%) |
| no Intervention | — | 0/24 (0%) | 0/24 (0%) |
The number of participants in the cNEP group was estimated from the number required to show a 50% decrease in the primary endpoint compared to the no intervention group.
| Age, Continuous(years) | Active cNEP @ -45cmw | no Intervention | Total |
|---|---|---|---|
| Mean | 60 (33 to 78) | 60 (34 to 77) | 60 (33 to 78) |
| Age, Categorical(Participants) | Active cNEP @ -45cmw | no Intervention | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 18 | 40 |
| >=65 years | 8 | 6 | 14 |
| Sex: Female, Male(Participants) | Active cNEP @ -45cmw | no Intervention | Total |
|---|---|---|---|
| Female | 18 | 9 | 27 |
| Male | 12 | 15 | 27 |
| Region of Enrollment(participants) | Active cNEP @ -45cmw | no Intervention | Total |
|---|---|---|---|
| United States | 30 | 24 | 54 |
| History of sleep apnea(participants) | Active cNEP @ -45cmw | no Intervention | Total |
|---|---|---|---|
| Number | 2 | 2 | 4 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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