CNAP Accuracy in the Bariatric Surgery Population

Not Applicable

Completed

• Conditions: Bariatric Surgery
• Interventions: Device: CNAP monitor

• Registration Number: NCT01896206
• Lead Sponsor: Joseph D. Tobias

Brief Summary

This study will compare accuracy of a newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) that provides beat-to-beat BP readings with two of the current and more commonly used intermittently oscillometric non-invasive blood pressure device (NIBP), and the invasive arterial line (IBP).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-07-08
• Study First Posted: 2013-07-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-02
• Results First Submitted: 2015-02-03
• Results First Submitted QC: 2015-02-25
• Last Update Submitted: 2015-02-25
• Results First Posted: 2015-02-27
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Patients who are scheduled for laparoscopic bariatric surgery for the treatment of obesity
• Patients in whom an indwelling arterial cannula will be placed for the surgical procedure

Exclusion Criteria

• Patients with history of a peripheral neurologic or neuropathic disorder
• Patients in whom an invasive arterial cannula cannot be placed
• Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm)
• Edematous patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CNAP monitor	CNAP monitor	Subjects undergoing bariatric surgery and monitored using the CNAP monitor.

Primary Outcome Measures

Name	Time	Method
The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.	Participants will be followed for the duration of surgery, an expected average of 2 hours.	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States