Optical System to Continuously Measure Arterial Blood Pressure

Blood Pressure Clinical Trial

— BP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651558
• Other study ID #: BLOOD PRESSURE
• Status: Completed
• Phase: N/A
• First received: December 17, 2015
• Last updated: April 10, 2018
• Start date: April 2016
• Est. completion date: November 1, 2017

Study information

• Verified date: April 2018
• Source: Centre Suisse d'Electronique et Microtechnique SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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
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
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.

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Suisse d'Electronique et Microtechnique SA	Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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