CNAP™ Monitor Study

Cardiac Surgery Clinical Trial

Official title:

Accuracy of the CNAP™ Monitor in Providing Beat-to-beat Non-invasive Blood Pressure Readings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356082
• Other study ID #: IRB11-00170
• 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

• Cardiac Surgery
• Spinal Surgery

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