CNAP Accuracy in the Bariatric Surgery Population

Bariatric Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896206
• Other study ID #: IRB12-00808
• Status: Completed
• Phase: N/A
• First received: June 27, 2013
• Last updated: February 25, 2015
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Device:
• CNAP monitor
Patients undergoing bariatric surgery and being monitored using the CNAP monitor.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.	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.	Participants will be followed for the duration of surgery, an expected average of 2 hours.	No