- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01356082
CNAP™ Monitor Study
May 1, 2012 updated by: Joseph D. Tobias, Nationwide Children's Hospital
Accuracy of the CNAP™ Monitor in Providing Beat-to-beat Non-invasive Blood Pressure Readings
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 16 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Surgery patients at Nationwide Children's Hospital receiving an arterial line.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Arterial blood pressure line
Patients receiving an arterial blood pressure line
|
Non-invasive blood pressure monitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure
Time Frame: 1 Day (day of surgery)
|
1 Day (day of surgery)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
May 17, 2011
First Submitted That Met QC Criteria
May 18, 2011
First Posted (Estimate)
May 19, 2011
Study Record Updates
Last Update Posted (Estimate)
May 2, 2012
Last Update Submitted That Met QC Criteria
May 1, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- IRB11-00170
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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