Blood Gas Monitoring, TranscutaneousNCT00247949
Accuracy of Non-invasive Continuous CO2-Monitoring
An observational study of Blood Gas Monitoring, Transcutaneous, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Gas Monitoring, Transcutaneous
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2004to Feb 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing surgery in general anesthesia and with clinical indication for repeated arterial blood gas sampling
Who may be able to join
- Patients older than 18 years with clinical indication of repeated arterial blood gas analyses
Who cannot join
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Gas Monitoring, Transcutaneous
- Keywords
- carbon dioxide, monitoring, major surgery, repeated blood gas testing, carbon dioxide monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startJul 2004
- Primary completionFeb 2006
- Study completionFeb 2006
Why it stopped: We had got enough data, therefore we stopped the study and published the data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Gas Monitoring, TranscutaneousStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- SenTec AG, Ringstrasse 39, CH-4106 Therwil
- Investigators
- Daniel Bolliger, Dr., Principal investigator, Department of Anaesthesia University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247949
- Sponsor's protocol ID
- 52/04
- Status last verified
- Nov 2009
- First submitted
- 1 Nov 2005
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Non-invasive Continuous Carbon Dioxide Monitoring by the Sentec V-Sign Digital Monitor System
- ClinicalTrials.gov ID
- NCT00247949
- Acronym / sponsor ID
- 52/04
- Conditions
- Blood Gas Monitoring, Transcutaneous
- Keywords
- carbon dioxide, monitoring, major surgery, repeated blood gas testing, carbon dioxide monitoring
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We had got enough data, therefore we stopped the study and published the data.
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- SenTec AG, Ringstrasse 39, CH-4106 Therwil
- Study start
- Jul 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 2 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing surgery in general anesthesia and with clinical indication for repeated arterial blood gas sampling
Key inclusion criteria (1 listed)
- Patients older than 18 years with clinical indication of repeated arterial blood gas analyses
Key exclusion criteria (1 listed)
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: We had got enough data, therefore we stopped the study and published the data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2009.
Related trials for Blood Gas Monitoring, Transcutaneous
RecruitingObservational study
Transcutaneous pO₂ Monitoring in PICU
Pediatric Critical Illness
RecruitingObservational study
Comparison of Transcutaneous and Blood CO₂ Measurement in Critically Ill Children
Respiratory Insufficiency in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Bolliger, Dr. principal investigator
Department of Anaesthesia University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Gas Monitoring, Transcutaneous, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We had got enough data, therefore we stopped the study and published the data.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2009.