Respiratory Variability in Aortic Blood Velocity Measured by Suprasternal View as an Indicator of Fluid Responsiveness (SUPRA-PAM)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular System
• Intervention / Treatment: Device: Fluid challenge with 250 ml of Ringer Lactate

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69002
    • Hôpital de la Croix-Rousse, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluid challenge with 250 ml of Ringer Lactate	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of percentage of cardiac flow variability between transthoracic and suprasternal views	Echographic measures will be realized a first time before fluid challenge by transthoracic and by suprasternal view and a second time after the fluid challenge by transthoracic and by suprasternal view.	At day 1(before surgery)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Pauline Devauchelle, MD, Hopital de la Croix-Rousse

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: June 1, 2016
• First Posted (Estimate): June 7, 2016

Study Record Updates

• Last Update Posted (Estimate): June 7, 2016
• Last Update Submitted That Met QC Criteria: June 1, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: fluid responsiveness; echography; Suprasternal
• Other Study ID Numbers: 69HCL14-0408