Skip to main content
OpenTrials
Completed

NCT Number: NCT02651558

Optical System to Continuously Measure Arterial Blood Pressure

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUV

Lausanne, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: OBPM 2015-MD-0022 - CHEST

Device

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

Device

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

Device

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.

Primary outcomes

  1. Error (in mmHg) between paired determinations of arterial blood pressure from an optical device against reference measurements from an arterial catheter

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Industry

Collaborators

  • Centre Hospitalier Universitaire Vaudois

Registry information

Official study title

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

Acronym: BP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2016
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.