Optical System to Continuously Measure Arterial Blood Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-11-01

Brief Summary

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

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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

Conditions

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Blood Pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OBPM 2015-MD-0022 - CHEST

Cohort of 30 patients undergoing general anesthesia, monitored by optical signals at the chest

Group Type EXPERIMENTAL

Experimental: OBPM 2015-MD-0022 - CHEST

Intervention Type DEVICE

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.

OBPM 2015-MD-0022 - CHEST & FINGER

Cohort of 10 patients undergoing general anesthesia, monitored by optical signals at the chest and at the fingertip

Group Type EXPERIMENTAL

Experimental: OBPM 2015-MD-0022 - CHEST & FINGER

Intervention Type DEVICE

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.

OBPM 2015-MD-0022 - FINGER

Cohort of 30 patients undergoing general anesthesia, monitored by optical signals at the fingertip

Group Type EXPERIMENTAL

Experimental: OBPM 2015-MD-0022 - FINGER

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE