Accuracy of Non-invasive Continuous CO2-Monitoring

Blood Gas Monitoring, Transcutaneous Clinical Trial

Official title:

The Accuracy of Non-invasive Continuous Carbon Dioxide Monitoring by the Sentec V-Sign Digital Monitor System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00247949
• Other study ID #: 52/04
• Status: Terminated
• Phase: Phase 4
• First received: November 1, 2005
• Last updated: November 9, 2009
• Start date: July 2004
• Est. completion date: February 2006

Study information

• Verified date: November 2009
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical 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) 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Gas Monitoring, Transcutaneous

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel	CH

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	SenTec AG, Ringstrasse 39, CH-4106 Therwil

Country where clinical trial is conducted

Switzerland,