CNAP Accuracy in the Bariatric Surgery Population
1 other identifier
interventional
21
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 27, 2013
CompletedFirst Posted
Study publicly available on registry
July 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
February 27, 2015
CompletedFebruary 27, 2015
February 1, 2015
6 months
June 27, 2013
February 3, 2015
February 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
CNAP monitor
EXPERIMENTALSubjects undergoing bariatric surgery and monitored using the CNAP monitor.
Interventions
Patients undergoing bariatric surgery and being monitored using the CNAP monitor.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joseph D. Tobiaslead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Results Point of Contact
- Title
- Joseph D. Tobias, MD
- Organization
- Nationwide Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph D Tobias, MD
Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chairman - Dept. of Anesthesiology & Pain Medicine
Study Record Dates
First Submitted
June 27, 2013
First Posted
July 11, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
February 27, 2015
Results First Posted
February 27, 2015
Record last verified: 2015-02