CNAP™ Monitor Study

NCT ID: NCT01356082

Last Updated: 2012-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-04-30

Brief Summary

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A newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) provides beat-to-beat BP readings and is non-invasive. To make sure that anaesthesiologist can rely on and make clinical decisions based on values provided by the CNAP™ monitor, to demonstrate its reliability we will test it during the perioperative care of children.

Detailed Description

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Conditions

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Cardiac Surgery Spinal Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Arterial blood pressure line

Patients receiving an arterial blood pressure line

CNAP

Intervention Type DEVICE

Non-invasive blood pressure monitor

Interventions

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CNAP

Non-invasive blood pressure monitor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who will already be having an indwelling arterial cannula placed for their 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.
* Patients who are less than 20 kg.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Tobias

Chairman Dept. of Anesthesiology & Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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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IRB11-00170

Identifier Type: -

Identifier Source: org_study_id

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