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CompletedNCT01003665Updated Apr 16, 2012

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

An observational study in Blood Pressure, sponsored by University Hospital Schleswig-Holstein. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-16.

Sponsored by University Hospital Schleswig-Holstein · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
195
Ages
18 Years and older
Sex
All
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Study summary

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
Read the detailed description

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.

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Conditions studied

  • Blood Pressure
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In context

Lead sponsor

University Hospital Schleswig-Holstein is the lead sponsor of 157 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients undergoing major surgery or intensive care unit treatement with the need for an invasive blood pressure measurement

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
195 participants (actual)

Groups and cohorts

  • Intensive Care treatement

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

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What researchers measure

Primary outcomes

  1. Bias and percentage error of CNAP compared with invasive arterial pressure measurement

    Time frame: 1.) Induction of general anaesthesia. 2.) Maintanance of general anaesthesia. 3.) Intensive Care Treatement after surgery

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Study locations

1 site
  • Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinik Schleswig-Holstein, Campus Kiel
    Kiel, 24106, Germany
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References and documents

Publications

  • 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. PubMed 22171358 ↗
  • 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. PubMed 25105850 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01003665
Lead sponsor
University Hospital Schleswig-Holstein
Responsible party
Robert Hanss (Prof. Dr. Robert Hanss, University Hospital Schleswig-Holstein) — Principal investigator
First posted
Oct 29, 2009
Start date
Feb 2009
Primary completion
May 2010
Completion
Jan 2012
Last update
Apr 16, 2012

Study contacts

Markus Steinfath, Professor
study chair · Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel
Robert Hanss, Professor
study director · Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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