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

NCT01003665 | Completed

• 1 other identifier: CNAP-2009-1
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

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

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (1)

Intensive Care treatement

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

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

Kiel, 24106, Germany

Location

Related Publications (2)

• 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.

  PMID: 22171358 RESULT

• 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.

  PMID: 25105850 DERIVED

Study Officials

• Markus Steinfath, Professor

  Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel

  STUDY CHAIR

• Robert Hanss, Professor

  Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Robert Hanss

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 29, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: January 1, 2012
• Last Updated: April 16, 2012

Record last verified: 2012-04

Locations

DE (1)