Optical System to Continuously Measure Arterial Blood Pressure (BP)

Swiss Center for Electronics and Microtechnology (CSEM)

Status: Completed

Conditions: Blood Pressure

Treatments: Device: Experimental: OBPM 2015-MD-0022 - FINGER; Device: Experimental: OBPM 2015-MD-0022 - CHEST; Device: Experimental: OBPM 2015-MD-0022 - CHEST & FINGER

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02651558

BLOOD PRESSURE

Details and patient eligibility

About

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

Full 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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

OBPM 2015-MD-0022 - CHEST

Experimental group

Description:

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

Treatment:

Device: Experimental: OBPM 2015-MD-0022 - CHEST

OBPM 2015-MD-0022 - CHEST & FINGER

Experimental group

Description:

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

Treatment:

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

OBPM 2015-MD-0022 - FINGER

Experimental group

Description:

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

Treatment:

Device: Experimental: OBPM 2015-MD-0022 - FINGER