This trial is active, not recruiting.

Condition blood pressure
Treatment csem bp system 2015-md-0022
Sponsor Centre Suisse d'Electronique et Microtechnique SA
Collaborator Centre Hospitalier Universitaire Vaudois
Start date December 2015
End date December 2016
Trial size 40 participants
Trial identifier NCT02651558, BLOOD PRESSURE


Comparison of an optical method to continuously measure blood pressure against an invasive arterial catheter.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Cohort of 40 patients undergoing general anesthesia
csem bp system 2015-md-0022
At the onset of general anesthesia: continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor) continuous estimates of optical blood pressure values (optical blood pressure system, via Swissmedic approved measuring device 2015-MD-0022 developed by CSEM) will be recorded.

Primary Outcomes

Error (in mmHg) between paired determinations of mean arterial blood pressure from an optical device against reference measurements from an arterial catheter
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - patient requiring the placement of an arterial catheter for general anesthesia - minimum of 18 years - written consent Exclusion Criteria: - minor patient or incapable of discernment - patient with AIMD - thoracic surgery

Additional Information

Official title Comparison of an Optical System to Continuously Measure Arterial Blood Pressure Against a Gold-standard Arterial Catheter
Principal investigator Patrick Schoettker
Description The measurement of blood pressure during anesthesia is commonly performed by the inflation of a brachial cuff providing only intermittent blood pressure measurements. In some case, it is required to add a continuous invasive monitoring of blood pressure, via the insertion of an arterial catheter. Unfortunately, the related morbidity is not negligible. To limit the consequences of such a gesture, some developments have been done in the past to allow for continuous non-invasive measurements of blood pressure during anesthesia. Unfortunately, most of these devices are subject to important limitations and constraints of use. A new system has been designed by CSEM consisting of an optical system fixed on patient's skin, absolutely non-invasive and easy to use. In order to study the reliability of this device, the investigators plan to compare its blood pressure estimates against gold-standard arterial catheter measurements during induction of general anesthesia on 40 patients.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Centre Suisse d'Electronique et Microtechnique SA.