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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02791984
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arm: 1
• Duration (Months): 11
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: N/A
• 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: Apr 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of cardiac flow variability [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital de la Croix-Rousse, Hospices Civils de Lyon	Lyon		France	69002

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

• Principal Investigator: Pauline Devauchelle, MD, Hopital de la Croix-Rousse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT02791984
• Other Study ID Numbers: 69HCL14-0408
• First Posted: Jun 7, 2016
• Last Update Posted: Jun 7, 2016
• Last Verified: May 1, 2016

• Keywords provided by Hospices Civils de Lyon: Suprasternal; echography; fluid responsiveness

Study Results

No Results Posted as of Jun 7, 2016