Preoperative Evaluation of Microcirculation for Prediction of Complications After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Cardiac surgery is responsible for many complications. Microcirculation is involved in many of them. The objective of this study is to prospectively investigate the prognostic value of preoperative microcirculatory assessment in patients scheduled for cardiac surgery with CPB for the occurrence of postoperative complications. Microvascular dysfunction is suspected of being involved in postoperative psycho-cognitive decline. The influence of microcirculation on the evolution of psycho-cognitive assessment is also analyzed in this study.

Detailed Description
-----------------
Eligible patients are included during the preoperative assessment. Written consent is signed after complete explanation of the protocol. Patient characteristics as treatments, medical history, and EuroSCORE II are registered. Moreover, intraoperative data is collected. Psycho-cognitive and functional evaluation is made preoperatively. Microcirculation is evaluated for each patient before surgery. Complications are registered at the end of hospital stay. Psycho-cognitive and functional evaluation is repeated by call 30 days after the surgery.

Official Title
-----------------
L'Etude préopératoire de la Microcirculation Pour la prédiction Des Complications après Une Chirurgie Cardiaque Sous Circulation Extracorporelle.

Conditions
-----------------
Extracorporeal Circulation; Complications

Intervention / Treatment
-----------------
* Procedure: Microvascular reactivity evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Valvular ou coronary elective cardiac surgery under cardiopulmonary bypass Fair skin phototype Ability to understand the study goal, no dementia. Affiliation to the French National Healthcare System Voluntary patients who have signed an informed consent Exclusion Criteria: Emergency surgery Multiple procedures, combined surgery (valvular and coronary) Single aortic surgery Patient already included in the study (second surgery) Patients protected by decision of law

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microvascular reactivity evaluation<br>Patients referred for a preoperative arterial palmar arches assessment before cardiac valvular or coronary surgery. Intervention is measurement of microvascular reactivity with a laser speckle contrast imaging before surgery. | Procedure: Microvascular reactivity evaluation<br>* Microcirculation will be evaluated for each patient before surgery with a laser speckle contrast imaging (LSCI) placed on the forearm. Tests will be performed for evaluation of endothelium reactivity: Iontophoresis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication | Composite criteria and include microcirculation postoperative complications: Late surgical re-intervention (greater than 12 hours) for evacuation of pericardial effusion (seeps), Surgical wound disunion or surgical site infection, Organ failure: SOFA score greater than 2 at 48h, Postoperative confusion: assessed using the Confusion Assessment Method (CAM) or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Acute renal failure ≥ stage 2 according to the KDIGO classification, Acute lung injury defined as PaO2 <55mmHg in ambient air, PaO2 / FiO2 ratio <250 or Pulse Oxygen Saturation (SpO2) <90% and need for oxygen therapy, Atrial fibrillation (excluding patients with permanent Atrial Fibrillation preoperatively), Hepatocellular injury (Cytolysis > 10N, Prothrombin rate and Factor V decreased < 60%). | 30 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of degree of disability | Change of modified Rankin scale | Inclusion and 30 days after surgery | 
| Functional evolution | Change of ADL score | Inclusion and 30 days after surgery | 
| Mood evolution | Change of brief Geriatric Depression Scale | Inclusion and 30 days after surgery | 
| Cognitive evolution | Change of Mc Nair test | Inclusion and 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic Surgery, Microcirculation, Endothelium, vascular, Microvascular reactivity, Laser Speckle