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CNAP™ Monitor Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01356082
First received: May 17, 2011
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Cardiac Surgery
Spinal Surgery
 Device: CNAP

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy of the CNAP™ Monitor in Providing Beat-to-beat Non-invasive Blood Pressure Readings

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 1 Day (day of surgery) ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: May 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arterial blood pressure line
Patients receiving an arterial blood pressure line
 Device: CNAP
Non-invasive blood pressure monitor

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Surgery patients at Nationwide Children's Hospital receiving an arterial line.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356082

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Joseph D. Tobias, Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01356082     History of Changes
Other Study ID Numbers: IRB11-00170
Study First Received: May 17, 2011
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013