Optical System to Continuously Measure Arterial Blood Pressure

Not Applicable

Completed

• Conditions: Blood Pressure

• Registration Number: NCT02651558
• Lead Sponsor: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Study Start: 2016-04
• Primary Completion: 2017-11-01
• Study Completion: 2017-11-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHUV; 🇨🇭 Lausanne, Switzerland