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Accuracy of Non-invasive Continuous CO2-Monitoring

This study has been terminated.
(We had got enough data, therefore we stopped the study and published the data.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00247949
First Posted: November 2, 2005
Last Update Posted: November 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
SenTec AG, Ringstrasse 39, CH-4106 Therwil
Information provided by:
University Hospital, Basel, Switzerland
  Purpose
Arterial carbon dioxide partial pressure (PaCO2) is an essential indicator of ventilation and respiratory function. It is routinely tested invasively by arterial blood gas analysis (ABGA) but recently developed miniaturized carbon dioxide tension sensors promise non-invasive and continuous transcutaneous PCO2 (PtcCO2) monitoring. We, the researchers at University Hospital, Basel, Switzerland, determined the accuracy of two PtcCO2 monitors (TOSCA 500 with Sensor 92, Linde Medical Sensors AG, Basel; and Sentec Digital Monitor with V-Sign Sensor, Sentec AG, Therwil) for measurement of single values and trends in PaCO2 in critically ill patients, using ABGA as a reference.

Condition Phase
Blood Gas Monitoring, Transcutaneous Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Accuracy of Non-invasive Continuous Carbon Dioxide Monitoring by the Sentec V-Sign Digital Monitor System

Further study details as provided by University Hospital, Basel, Switzerland:

Enrollment: 150
Study Start Date: July 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:
Measurement of SO2 is used in nearly every patient receiving anesthesia or sedation, whereas monitoring of pCO2 is important in patients during and shortly after major surgery and in critically ill patients. But measurement of pCO2 requires arterial blood sampling and laboratory testing. Non-invasive monitors for continuous assessment of arterial pCO2 have been developed but their accuracy and feasibility were insufficient to make them useful in the clinical setting. Recently, a new digital system for continuous and non-invasive monitoring of arterial pCO2 and SO2 has been introduced (SenTec Digital Monitor System, SenTec AG, Therwil, Switzerland). This present study has been designed to evaluate the accuracy of the SenTec V-SignTM monitoring system for measuring pCO2 in comparison with repeated arterial blood gas testing in the operation room and in the intensive care unit.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients undergoing surgery in general anesthesia and with clinical indication for repeated arterial blood gas sampling
Criteria

Inclusion Criteria:

  • Patients older than 18 years with clinical indication of repeated arterial blood gas analyses

Exclusion Criteria:

  • No informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247949


Locations
Switzerland
University Hospital
Basel, CH, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
SenTec AG, Ringstrasse 39, CH-4106 Therwil
Investigators
Principal Investigator: Daniel Bolliger, Dr. Department of Anaesthesia University Hospital Basel
  More Information

Responsible Party: Dr. D. Bolliger, MD
ClinicalTrials.gov Identifier: NCT00247949     History of Changes
Other Study ID Numbers: 52/04
First Submitted: November 1, 2005
First Posted: November 2, 2005
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by University Hospital, Basel, Switzerland:
carbon dioxide
monitoring
major surgery
repeated blood gas testing
carbon dioxide monitoring