NCT01356082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

May 2, 2012

Status Verified

May 1, 2012

Enrollment Period

11 months

First QC Date

May 17, 2011

Last Update Submit

May 1, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    1 Day (day of surgery)

Study Arms (1)

Arterial blood pressure line

Patients receiving an arterial blood pressure line

Device: CNAP

Interventions

CNAPDEVICE

Non-invasive blood pressure monitor

Arterial blood pressure line

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Surgery patients at Nationwide Children's Hospital receiving an arterial line.

You may qualify if:

  • Patients who will already be having an indwelling arterial cannula placed for their surgical procedure.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 19, 2011

Study Start

May 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 2, 2012

Record last verified: 2012-05

Locations