Extracorporeal Circulation; Complications
Conditions
Keywords
Thoracic Surgery, Microcirculation, Endothelium, vascular, Microvascular reactivity, Laser Speckle
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.
Interventions
PROCEDUREMicrovascular reactivity evaluation
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.
Sponsors
University Hospital, Angers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complication | 30 postoperative days | 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%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of degree of disability | Inclusion and 30 days after surgery | Change of modified Rankin scale |
| Functional evolution | Inclusion and 30 days after surgery | Change of ADL score |
| Mood evolution | Inclusion and 30 days after surgery | Change of brief Geriatric Depression Scale |
| Cognitive evolution | Inclusion and 30 days after surgery | Change of Mc Nair test |
Countries
France
Outcome results
None listed