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Accuracy of Non-invasive Continuous CO2-Monitoring

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Terminated
CT.gov ID
NCT00247949
Collaborator
SenTec AG, Ringstrasse 39, CH-4106 Therwil (Other)
150
Enrollment
1
Location
19.1
Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    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
    Study Start Date :
    Jul 1, 2004
    Actual Primary Completion Date :
    Feb 1, 2006
    Actual Study Completion Date :
    Feb 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Patients older than 18 years with clinical indication of repeated arterial blood gas analyses
      Exclusion Criteria:
      • No informed consent

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00247949
      Other Study ID Numbers:
      • 52/04
      First Posted:
      Nov 2, 2005
      Last Update Posted:
      Nov 10, 2009
      Last Verified:
      Nov 1, 2009
      Keywords provided by , ,
      carbon dioxide
      monitoring
      major surgery
      repeated blood gas testing
      carbon dioxide monitoring

      Study Results

      No Results Posted as of Nov 10, 2009