Comparison of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Arterial Pressure Monitoring

NCT ID: NCT01003665

Last Updated: 2012-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study was to compare the Continuous Non-invasive Arterial Pressure (CNAP) monitor with the gold standard of invasive arterial pressure monitoring during:

1. induction and maintenance of general anaesthesia
2. intensive care unit treatment of postoperative patients with an ASA 3 or 4 status

Detailed Description

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The CNAP monitor continuously measures blood pressure using a finger cuff. It showed a good agreement to invasive blood pressure measurements during anaesthesia induction and maintenance during surgery. In critical ill patients cardiac arrhythmia is probably a confounding factor affecting accuracy and interchangeability of CNAP. As systolic arterial CNAP pressure in comparison to mean pressure shows no statistical interchangeability with invasive measurements, mean pressure should be considered when making therapy decisions.

A problem is the missing standard criterion for comparison of continuously devices with invasive pressure.

Conditions

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Blood Pressure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Intensive Care treatement

ASA status 3 or 4 patients with invasive blood pressure measurement on the intensive care unit

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \>18
* BMI \< 35 kg.m²
* Patients capable of giving informed consent
* patients undergoing elective surgical procedures in supine position under general anesthesia
* perfusion of the examined arm evidenced by a positive Allen's test

Exclusion Criteria

* Patients not competent or unwilling to provide informed consent
* Patients with history of neurological, neuromuscular seizure
* Patients where IBP cannula, CNAP™ finger-cuff and CNAP™ upper arm cuff cannot be placed on the same arm
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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Robert Hanss

Prof. Dr. Robert Hanss

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Steinfath, Professor

Role: STUDY_CHAIR

Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel

Robert Hanss, Professor

Role: STUDY_DIRECTOR

Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel

Locations

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Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinik Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Site Status

Countries

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Germany

References

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Ilies C, Bauer M, Berg P, Rosenberg J, Hedderich J, Bein B, Hinz J, Hanss R. Investigation of the agreement of a continuous non-invasive arterial pressure device in comparison with invasive radial artery measurement. Br J Anaesth. 2012 Feb;108(2):202-10. doi: 10.1093/bja/aer394. Epub 2011 Dec 12.

Reference Type RESULT
PMID: 22171358 (View on PubMed)

Ilies C, Grudev G, Hedderich J, Renner J, Steinfath M, Bein B, Haake N, Hanss R. Comparison of a continuous noninvasive arterial pressure device with invasive measurements in cardiovascular postsurgical intensive care patients: a prospective observational study. Eur J Anaesthesiol. 2015 Jan;32(1):20-8. doi: 10.1097/EJA.0000000000000136.

Reference Type DERIVED
PMID: 25105850 (View on PubMed)

Other Identifiers

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CNAP-2009-1

Identifier Type: -

Identifier Source: org_study_id

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