Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium

Myocardial Dysfunction Clinical Trial

— ECHOPOG  

Official title:

Evaluation of Left Ventricular Filling Pressures in Post-operative Cardiac Surgery: Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03012308
• Other study ID #: 6655 - ECHOPOG
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2017
• Last updated: May 11, 2017
• Start date: December 20, 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: January 2017
• Source: University Hospital, Strasbourg, France
• Contact: Gharib AJOB, MD
• Phone: 33 3 69 54 97 58
• Email: gharib.ajob[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

As part of cardiac and hemodynamic evaluation of patients, echocardiographic measurements allow indirect evaluation of left ventricular filling pressures (LVFP). These ultrasound parameters, including mitral valve doppler and mitral ring doppler (in particular the E / E 'ratio), are well validated in medical cardiology and in some resuscitation patients. The measurement of filling pressures is an important daily element in the medical management of patients in intensive care, in particular on the hemodynamic and respiratory levels. No studies have evaluated the relevance of these markers in a postoperative context of cardiac surgery. Indeed, the surgery alters the cardiac function, which could modify the values of the echocardiographic parameters and their predictability. Left atrium pressure (LAP) directly reflects LVFP and is measured in cardiac surgical resuscitation by a surgically placed catheter as part of routine institutional care and will serve as gold-standard. To study the clinical significance of these LAP and LVFP values estimated by cardiac ultrasound, we will study their correlation with clinical and ultrasound signs of acute lung edema (ALE).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient hospitalized in surgical resuscitation for cardiac surgery with heart-lung bypass machine

Exclusion Criteria:

• No consent

• Mitral valve surgery

• severe MI / severe mitral narrowing.

• Absence of POG catheter

• Urgent surgery

• Heart transplant / mechanical assistance

• Classics: minors, pregnant women, guardianship / curatorship / safeguarding,

Related Conditions & MeSH terms

• Myocardial Dysfunction

Locations

Country	Name	City	State
France	Service Réanimation chirurgicale cardio-vasculaire - NHC	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the mean values of LAP between the group "high filling pressures" and the group "non-high filling pressures"		6 postoperative hours of cardiac surgery of patients hospitalized in surgical resuscitation