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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01356082
Other study ID # IRB11-00170
Secondary ID
Status Completed
Phase N/A
First received May 17, 2011
Last updated May 1, 2012
Start date May 2011
Est. completion date April 2012

Study information

Verified date May 2012
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 18 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
CNAP
Non-invasive blood pressure monitor

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure 1 Day (day of surgery) No
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