Trial Outcomes & Findings for CNAP Accuracy in the Bariatric Surgery Population (NCT NCT01896206)

Results Overview

To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Participants will be followed for the duration of surgery, an expected average of 2 hours.

Results posted on

2015-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	CNAP Monitor Subjects undergoing bariatric surgery and monitored using the CNAP monitor. CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CNAP Accuracy in the Bariatric Surgery Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CNAP Monitor n=21 Participants Subjects undergoing bariatric surgery and monitored using the CNAP monitor. CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor.
Age, Categorical <=18 years	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	17.55 years STANDARD_DEVIATION 2.53 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants will be followed for the duration of surgery, an expected average of 2 hours.

Population: The initial study cohort included 21 patients; however, the finger cuff was expired in 1 patient, resulting in no data collection, and the data from 2 other patients were lost in the download to the electronic medical record system.

To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg.

Outcome measures

Outcome measures
Measure	CNAP Monitor n=18 Participants Subjects undergoing bariatric surgery and monitored using the CNAP monitor. CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor.
The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.	7.7 mmHg Standard Deviation 4.9

Adverse Events

CNAP Monitor

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

Joseph D. Tobias, MD

Nationwide Children's Hospital

Phone: 6147224200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place