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

NCT02791984 | Completed

• 1 other identifier: 69HCL14-0408
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular System

Keywords

Suprasternal; echography; fluid responsiveness

Outcome Measures

Primary Outcomes (1)

• Percentage of cardiac flow variability

  Percentage of cardiac flow variability between the 2 echographic measures. Echographic measures will be realized a first time before fluid challenge by suprasternal view and a second time after the fluid challenge by suprasternal view.

  At day 1(before surgery)

Secondary Outcomes (1)

• Comparison of percentage of cardiac flow variability between transthoracic and suprasternal views

  At day 1(before surgery)

Study Arms (1)

Fluid challenge with 250 ml of Ringer Lactate

EXPERIMENTAL

Device: Fluid challenge with 250 ml of Ringer Lactate

Interventions

Fluid challenge with 250 ml of Ringer Lactate 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

Fluid challenge with 250 ml of Ringer Lactate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Arrhythmia
• Spontaneous breathing activity
• Significant valvular disease

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital de la Croix-Rousse, Hospices Civils de Lyon

Lyon, 69002, France

Location

Study Officials

• Pauline Devauchelle, MD

  Hopital de la Croix-Rousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 7, 2016
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 7, 2016

Record last verified: 2016-05

Locations

FR (1)