NCT02651558

Optical System to Continuously Measure Arterial Blood Pressure

Comparison of an Optical System to Continuously Measure Arterial Blood Pressure Against a Gold-standard Arterial Catheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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 wearing the optical system at the chest. * and 40 patients wearing the optical system at the fingertip

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	Experimental: OBPM 2015-MD-0022 - CHEST	At the onset of general anesthesia: 1. continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor) 2. continuous estimates of optical blood pressure values at the chest (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded.
DEVICE	Experimental: OBPM 2015-MD-0022 - CHEST & FINGER	At the onset of general anesthesia: 1. continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor) 2. continuous estimates of optical blood pressure values at the chest (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) 3. continuous estimates of optical blood pressure values at the fingertip (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded.
DEVICE	Experimental: OBPM 2015-MD-0022 - FINGER	At the onset of general anesthesia: 1. continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor) 2. continuous estimates of optical blood pressure values at the fingertip (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2016-01-11
• Last updated: 2018-04-12

Locations

1 site across 1 country: Switzerland