Study of Perioperative Evolution of Right Heart Dysfunction and Preload Responsiveness in Open Heart Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to assess the ability a Lung Recruitment Maneuver (LRM) with a stepwise increase of PEEP to predict fluid responsiveness and right cardiac dysfunction in mechanically ventilated patients in open heart cardiac surgery. During different phases, all patients received a Passive Leg Raising (PLR) maneuver for preload status evaluation using the PICCO system, a Lung Recruitment Maneuver (LRM) and an echographic evaluation of the right cardiac function. 20 patients were analyzed. Incomplete Lung Recruitment Maneuver (LRM) can predict fluid responsiveness at phase 1, pre-operatively, with a sensitivity of 0.57 and specificity of 0.62. Performance of an incomplete Magnetic Resonance Angiography (MRA) to predict right cardiac dysfunction based on TAPSE post-operatively provides a sensitivity and specificity of respectively 0.33 and 0.17 Tolerance to a stepwise lung recruitment maneuver can not be used to evaluate reliably the preload responsiveness and guide fluid therapy except pre-operatively. The use of a lung recruitment maneuver can be a promising method for right cardiac dysfunction screening but further studies need to be done with different echographic tools for right cardiac dysfunction evaluation.

Official Title
-----------------
Study of Perioperative Evolution of Right Heart Dysfunction and Preload Responsiveness in Open Heart Cardiac Surgery

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Other: passive leg raising maneuver (PLR)
* Other: lung recruitment maneuver (LRM)
* Other: echographic evaluation of the right cardiac function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving an elective or urgent cardiac surgery with or without extracorporeal circulation under general anesthesia, under protective mechanical ventilation, monitored by invasive arterial blood pressure and pulse contour analysis (PICCO system) for cardiac output measurement and central venous pressure Exclusion Criteria: Left ventricular ejection fraction ≤ 30% heart arrhythmia, pulmonary hypertension (SPAP > 35 mmHg) right heart failure (TAPSE < 16 mm, S' at lateral tricuspid valve < 10 cm/sec) lower limbs obstructive arteriopathy (stage IIb, III and IV) severe and very severe chronic obstructive pulmonary disease (COPD) pneumothorax and extreme weights (BMI < 35 kg/m2).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients receiving cardiac surgery<br>Patients receiving cardiac surgery will be included. All patients received a passive leg raising maneuver (PLR) for preload status evaluation using the PICCO system, a lung recruitment maneuver (LRM) and an echographic evaluation of the right cardiac function. | Other: passive leg raising maneuver (PLR)<br>* Passive leg raising maneuver (PLR) for preload status evaluation using the PICCO system will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit).<br>Other: lung recruitment maneuver (LRM)<br>* lung recruitment maneuver (LRM) will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit).<br>Other: echographic evaluation of the right cardiac function<br>* echographic evaluation of the right cardiac function will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid responsiveness measured with PiCCO system during Lung recruitment maneuver. | Measured by PICCO results (phase: 1, 2, 3). | Months: 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis Right cardiac function - Transthoracic echocardiography | measured with Transthoracic echocardiography (phase 1, 3). | Months: 4 | 
| Analysis Right cardiac function - transoesophageal echocardiography | measured with transoesophageal echocardiography (phase 1, 2). | Months: 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung recruitment maneuver, Fluid responsiveness, cardiac surgery, right cardiac dysfunction, passive leg raising, Transcardiopulmonary Thermodilution, Calibrated Arterial Waveform Analysis, echocardiography