Trial Outcomes & Findings for Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy (NCT NCT01895062)

NCT ID: NCT01895062

Last Updated: 2014-08-06

Results Overview

Mean RI events in the no cNEP group was 3.5 compared to 1.92 in the cNEP group (p=0.022)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 54 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2014-08-06

Participant Flow

Participant milestones

Measure	Active cNEP @ -45cmw cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source. 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.	no Intervention Routine care is administered without the application of cNEP.
Overall Study STARTED	30	24
Overall Study COMPLETED	30	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Active cNEP @ -45cmw n=30 Participants cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source. 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.	no Intervention n=24 Participants Routine care is administered without the application of cNEP.	Total n=54 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	60 years n=7 Participants	60 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	9 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	24 participants n=7 Participants	54 participants n=5 Participants
History of sleep apnea	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Not all subjects were evaluable due to malfunction of the respiratory monitoring equipment in several.

Mean RI events in the no cNEP group was 3.5 compared to 1.92 in the cNEP group (p=0.022)

Outcome measures

Measure	Active cNEP @ -45cmw n=29 Participants cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source. 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.	no Intervention n=24 Participants Routine care is administered without the application of cNEP.
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 RI events Interval 1.1 to 2.75	3.5 RI events Interval 2.37 to 4.64

SECONDARY outcome

Timeframe: 1 hour

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 hour

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 hour

interventions such as reduction of sedative medication or jaw thrust.

Outcome measures

Measure	Active cNEP @ -45cmw n=29 Participants cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source. 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.	no Intervention n=24 Participants Routine care is administered without the application of cNEP.
The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group.	1 interventions to restore airway	0 interventions to restore airway

Adverse Events

Active cNEP @ -45cmw

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Richard Rose

5i Sciences

Phone: 858-759-2205

Email: rrose@5isciences.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place