Optical System to Continuously Measure Arterial Blood Pressure (BP)

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

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

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: Experimental: OBPM 2015-MD-0022 - CHEST; Device: Experimental: OBPM 2015-MD-0022 - CHEST & FINGER; Device: Experimental: OBPM 2015-MD-0022 - FINGER

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland
    • CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OBPM 2015-MD-0022 - CHEST; Cohort of 30 patients undergoing general anesthesia, monitored by optical signals at the chest	Device: Experimental: OBPM 2015-MD-0022 - CHEST; 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.
Experimental: OBPM 2015-MD-0022 - CHEST & FINGER; 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; 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.
Experimental: OBPM 2015-MD-0022 - FINGER; Cohort of 30 patients undergoing general anesthesia, monitored by optical signals at the fingertip	Device: Experimental: OBPM 2015-MD-0022 - FINGER; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
• Collaborators: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Patrick Schoettker, CHUV

Publications and helpful links

General Publications

• Ghamri Y, Proenca M, Hofmann G, Renevey P, Bonnier G, Braun F, Axis A, Lemay M, Schoettker P. Automated Pulse Oximeter Waveform Analysis to Track Changes in Blood Pressure During Anesthesia Induction: A Proof-of-Concept Study. Anesth Analg. 2020 May;130(5):1222-1233. doi: 10.1213/ANE.0000000000004678.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: BLOOD PRESSURE