Viewing Study NCT02651558


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Study NCT ID: NCT02651558
Status: COMPLETED
Last Update Posted: 2018-04-12
First Post: 2015-12-17
Is Possible Gene Therapy: False
Has Adverse Events: False

Brief Title: Optical System to Continuously Measure Arterial Blood Pressure
Sponsor: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Organization:

Study Overview

Official Title: Comparison of an Optical System to Continuously Measure Arterial Blood Pressure Against a Gold-standard Arterial Catheter
Status: COMPLETED
Status Verified Date: 2018-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BP
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: