Respiratory Variability in Aortic Blood Velocity Measured by Suprasternal View as an Indicator of Fluid Responsiveness

NCT ID: NCT02791984

Last Updated: 2016-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-03-31

Brief Summary

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Respiratory changes in aortic blood velocity have been described as an indicator of fluid responsiveness when measured in the left ventricular outflow tract by trans esophageal echography. A threshold value of 12% allowed discrimination between responders and nonresponders with a sensitivity of 100% and a specificity of 89%. The suprasternal window is already used to measure cardiac output. The primary endpoint of this study is to determine the predictive value of the respiratory variability in aortic blood velocity measured by suprasternal view (∆VpicSS) as an indicator of fluid responsiveness. The secondary endpoint is to compare maximum velocity and velocity time integral measured by suprasternal and transthoracic view.

Detailed Description

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Conditions

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Cardiovascular System

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fluid challenge with 250 ml of Ringer Lactate

Group Type EXPERIMENTAL

Fluid challenge with 250 ml of Ringer Lactate

Intervention Type DEVICE

Fluid challenge with 250 ml of Ringer Lactate over less than 2 minutes, intra-venous, help by a syringe of 50 ml.

Measure of peak velocity before and after the fluid challenge

Interventions

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Fluid challenge with 250 ml of Ringer Lactate

Fluid challenge with 250 ml of Ringer Lactate over less than 2 minutes, intra-venous, help by a syringe of 50 ml.

Measure of peak velocity before and after the fluid challenge

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age more than 18 years
* American Society of Anesthesiologists (ASA) score 1 or 2
* General Anesthesia with mechanical ventilation
* General Surgery

Exclusion Criteria

* Arrhythmia
* Spontaneous breathing activity
* Significant valvular disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pauline Devauchelle, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital de la Croix-Rousse

Locations

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Hopital de la Croix-Rousse, Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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69HCL14-0408

Identifier Type: -

Identifier Source: org_study_id

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