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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014