The main objective of this study is to measure the incidence of postoperative infections in 2 groups of patients: one group of patients ventilated and one group of patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery, and demonstrate that the incidence of postoperative infections is significantly lower in patients ventilated during cardiopulmonary bypass.
Cardiopulmonary bypass (CBP) during cardiac surgery induces a systemic inflammatory response associated with an immune dysregulation and a significant pulmonary dysfunction. First, the inflammatory response, usually attributed to surgical trauma, contact of blood with artificial surfaces, and ischemia reperfusion injury, is responsible for a postoperative immunodepression. For instance, an early impairment of lung cellular immune response after CPB, which could promote the development of postoperative pneumonia, has been found. Along these lines, a downregulation of human leukocyte antigen-DR antigen (HLA-DR) expression on monocytes and an increase in plasma interleukin 10 (IL-10) associated with the occurrence of nosocomial infections have been reported. Second, CPB induces a pulmonary dysfunction, which ranges from a temporary and clinically insignificant reduction in arterial oxygenation to a life-threatening injury manifested as acute respiratory distress syndrome (ARDS). This phenomenon is of multifactorial sources, but one of the main mechanisms is the occurrence of atelectasis during surgery. Atelectasis has been associated with lung injury and release of cytokines by shear forces on alveoli and small airways. However, it is not clear whether this injury is due to a recruitment/derecruitment phenomenon (i.e., atelectrauma) or whether it might by itself lead to the release of cytokine. Since CPB mechanically circulates and oxygenates blood bypassing the heart and lungs, usual procedure during CPB is to stop mechanical ventilation (MV) (apnea). Nevertheless, maintaining MV with positive expiratory pressure (PEEP) during CPB diminished the occurrence of atelectasis and the postoperative inflammatory response. Thus, we investigated the effects of maintaining MV during CPB for cardiac surgery on postoperative immunodepression and found that maintaining MV during CPB decreased postoperative immune dysfunction and could be an interesting strategy to diminish the occurrence of postoperative infection (nosocomial infection) without hampering the surgical procedure. However, these findings have to be confirmed in a clinical trial using the incidence of nosocomial infection as an endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,401
dead space ventilation using tidal volume of 2.5 mL/kg/pbw (predicted body weight) with 5-7 cm H2O Positive end-expiratory pressure
absence of mechanical ventilation (and no Positive end-expiratory pressure) by disconnecting the tracheal tube from the ventilator
CHU Angers
Angers, France
CHU Bordeaux
Bordeaux, France
CHU Lille
Lille, France
Hôpital Pitié Salpêtrière
Paris, France
CHU Rennes
Rennes, France
Incidence of postoperative infections
Time frame: During 28 days
Expression of human leukocyte antigen-DR antigen (HLA-DR)
Time frame: At day 0, day 1 and day 7
Plasmatic concentration of interleukin 10 (IL10)
Time frame: At day 0, day 1 and day 7
Indoleamine 2,3-Dioxygenase (IDO) activity
Time frame: At day 0, day 1 and day 7
Proportion of myeloid-derived suppressor cells (MDSCs)
Time frame: At day 0, day 1 and day 7
Plasmatic concentration of interleukin 6 (IL-6)
Time frame: At day 0, day 1 and day 7
Quantity of extracellular vesicles (EV)
Time frame: At day 0 and day 1
Occurrence of lymphopenia
Time frame: At day 0, day 1 and day 7
Duration of antibiotic treatment
Time frame: During 28 days
Mortality
Time frame: During 28 days
Length of hospital stay
Time frame: During 28 days
PaO2/FiO2 ratio
Time frame: At day 0 and day 1
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CHU Toulouse
Toulouse, France
Duration of mechanical ventilation
Time frame: During 28 days