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CNAP Accuracy in the Bariatric Surgery Population

NCT ID: NCT01896206

Last Updated: 2015-02-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Bariatric Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CNAP monitor

Subjects undergoing bariatric surgery and monitored using the CNAP monitor.

Group Type EXPERIMENTAL

CNAP monitor

Intervention Type DEVICE

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

Interventions

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CNAP monitor

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joseph D. Tobias

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Tobias

Chairman - Dept. of Anesthesiology & Pain Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joseph D Tobias, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB12-00808

Identifier Type: -

Identifier Source: org_study_id