Optical System to Continuously Measure Arterial Blood Pressure

Study Overview
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Brief Summary
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Comparison of an optical method to continuously measure blood pressure against an invasive arterial catheter.

Detailed Description
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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

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

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: Experimental: OBPM 2015-MD-0022 - CHEST
* Device: Experimental: OBPM 2015-MD-0022 - CHEST & FINGER
* Device: Experimental: OBPM 2015-MD-0022 - FINGER


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OBPM 2015-MD-0022 - CHEST<br>Cohort of 30 patients undergoing general anesthesia, monitored by optical signals at the chest | Device: Experimental: OBPM 2015-MD-0022 - CHEST<br>* 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 at the chest (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded.<br>|
| Experimental: OBPM 2015-MD-0022 - CHEST & FINGER<br>Cohort of 10 patients undergoing general anesthesia, monitored by optical signals at the chest and at the fingertip | Device: Experimental: OBPM 2015-MD-0022 - CHEST & FINGER<br>* 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 at the chest (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) 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.<br>|
| Experimental: OBPM 2015-MD-0022 - FINGER<br>Cohort of 30 patients undergoing general anesthesia, monitored by optical signals at the fingertip | Device: Experimental: OBPM 2015-MD-0022 - FINGER<br>* 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 at the fingertip (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Error (in mmHg) between paired determinations of arterial blood pressure from an optical device against reference measurements from an arterial catheter | The signals recorded by the optical blood pressure device will be retrospectively analysed (offline analysis) in order to test the hypothesis that blood pressure values as derived by the new device is comparable to blood pressure values as measured by an arterial catheter within the limits of agreement in mmHg stated by ISO 81060-2 2013. | 24 months |