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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02791984
Recruitment Status : Completed
First Posted : June 7, 2016
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Cardiovascular System Device: Fluid challenge with 250 ml of Ringer Lactate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Respiratory Variability in Aortic Blood Velocity Measured by Suprasternal View as an Indicator of Fluid Responsiveness
Study Start Date : April 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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





Primary Outcome Measures :
  1. Percentage of cardiac flow variability [ Time Frame: At day 1(before surgery) ]
    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.


Secondary Outcome Measures :
  1. Comparison of percentage of cardiac flow variability between transthoracic and suprasternal views [ Time Frame: At day 1(before surgery) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791984


Locations
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France
Hopital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France, 69002
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Pauline Devauchelle, MD Hopital de la Croix-Rousse

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02791984    
Other Study ID Numbers: 69HCL14-0408
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: May 2016
Keywords provided by Hospices Civils de Lyon:
Suprasternal
echography
fluid responsiveness