Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium

NCT03012308 | Unknown

• 1 other identifier: 6655 - ECHOPOG
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Myocardial Dysfunction

Keywords

Myocardial Dysfunction; left ventricular; mitral valve doppler; mitral ring doppler; ultrasound signs; lung edema

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

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

Study Population

Patient hospitalized in surgical resuscitation for cardiac surgery with heart-lung bypass machine, aged over 18 years

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service Réanimation chirurgicale cardio-vasculaire - NHC

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gharib AJOB, MD

  University Hospital, Strasbourg, France

  STUDY DIRECTOR

• Paul-Michel MERTES, MD, PhD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gharib AJOB, MD

CONTACT

33 3 69 54 97 58; gharib.ajob@chru-strasbourg.fr

Paul-Michel MERTES, MD, PhD

CONTACT

33 3 69 55 15 78; paul-michel.mertes@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 6, 2017
• Study Start: December 20, 2016
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: May 12, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)