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CNAP™ Monitor Study

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ClinicalTrials.gov Identifier: NCT01356082
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : May 2, 2012
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Brief Summary:
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 or disease Intervention/treatment
Cardiac Surgery Spinal Surgery Device: CNAP

Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy of the CNAP™ Monitor in Providing Beat-to-beat Non-invasive Blood Pressure Readings
Study Start Date : May 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Group/Cohort Intervention/treatment
Arterial blood pressure line
Patients receiving an arterial blood pressure line
Device: CNAP
Non-invasive blood pressure monitor



Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 1 Day (day of surgery) ]


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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356082


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

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
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: May 2012