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

Tracking Information
First Received Date ^ICMJE	May 17, 2011
Last Updated Date	May 1, 2012
Start Date ^ICMJE	May 2011
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 18, 2011)	Blood pressure [ Time Frame: 1 Day (day of surgery) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01356082 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	CNAP™ Monitor Study
Official Title ^ICMJE	Accuracy of the CNAP™ Monitor in Providing Beat-to-beat Non-invasive Blood Pressure Readings
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Surgery patients at Nationwide Children's Hospital receiving an arterial line.
Condition ^ICMJE	Cardiac Surgery Spinal Surgery
Intervention ^ICMJE	Device: CNAP Non-invasive blood pressure monitor
Study Group/Cohort (s)	Arterial blood pressure line Patients receiving an arterial blood pressure line Intervention: Device: CNAP
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	46
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	5 Years to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01356082
Other Study ID Numbers ^ICMJE	IRB11-00170
Has Data Monitoring Committee	No
Responsible Party	Joseph D. Tobias, Nationwide Children's Hospital
Study Sponsor ^ICMJE	Nationwide Children's Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Nationwide Children's Hospital
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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