- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247949
Accuracy of Non-invasive Continuous CO2-Monitoring
November 9, 2009 updated by: University Hospital, Basel, Switzerland
The Accuracy of Non-invasive Continuous Carbon Dioxide Monitoring by the Sentec V-Sign Digital Monitor System
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.
Study Overview
Status
Terminated
Conditions
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 Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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CH
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Basel, CH, Switzerland, 4031
- University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients undergoing surgery in general anesthesia and with clinical indication for repeated arterial blood gas sampling
Description
Inclusion Criteria:
- Patients older than 18 years with clinical indication of repeated arterial blood gas analyses
Exclusion Criteria:
- No informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Daniel Bolliger, Dr., Department of Anaesthesia University Hospital Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
February 1, 2006
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
November 1, 2005
First Submitted That Met QC Criteria
November 1, 2005
First Posted (Estimate)
November 2, 2005
Study Record Updates
Last Update Posted (Estimate)
November 10, 2009
Last Update Submitted That Met QC Criteria
November 9, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 52/04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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