In patients undergoing lung transplantation (LT), the investigators hypothesize that a "systematic" intraoperative ECMO strategy would reduce the need for invasive mechanical ventilation in the first 28 days without increasing adverse events, as compared to an "on-demand" intraoperative ECMO strategy. To date, LT remains a highly hazardous procedure. Even if the surgical procedure is well established, the intraoperative support is not, and most intra-operative ECMO decisions rely on local protocols, anesthesiologists' habits, and surgeons' preference. The efficacy of applying a "systematic" strategy on reducing the occurrence of severe primary graft dysfunction and thus mechanical ventilation in the 28 days following LT, without increasing mortality or morbidity, would support future guidelines on the use of ECMO in the intraoperative period of LT for obstructive and restrictive lung diseases.
Lung transplantation (LT) provides the prospect of improved survival and quality of life for patients with end stage lung and pulmonary vascular diseases. Its performance carries significant adverse effects, being either intra- or postoperative. The ventilation of a diseased lung for sometimes extended periods and the risk of reperfusion oedema and primary graft dysfunction is a challenge. Moreover, significant hemodynamic instabilities episodes might occur, because of pressure on, or displacement of the heart, clamping of the pulmonary arteries and ischemia-reperfusion syndrome. veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has now replaced cardiopulmonary bypass for respiratory and hemodynamic intraoperative support, carrying less side effects, and an improved early survival. Even though ECMO is a widely used technique, no precise guideline exists on the hemodynamic and respiratory indexes in LT settings to initiate intraoperative ECMO, but only experts' opinion. Besides, it has to be underlined that the rate of LT performed in the absence of any mechanical support is highly variable among centres, ranging from being exceptional up to 70%. The investigators aim at evaluating two strategies of ECMO initiation in the pre- and intraoperative periods in patients with pulmonary disease requiring LT: an "on-demand" strategy, in which VA-ECMO will be initiated on high hemodynamic and respiratory needs thresholds and a "systematic" strategy in which VA-ECMO will be pre-emptively initiated. The investigators hypothesize that a "systematic" strategy allows to reduce the risk of severe primary graft dysfunction and the need for mechanical ventilator in the 28 days following LT without increasing adverse events
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
200
Strategy would reduce the need for invasive mechanical ventilation in the first 28 days without increasing adverse events
Hôpital Bichat Claude Bernard
Paris, France
RECRUITINGHôpital FOCH
Suresnes, France
NOT_YET_RECRUITINGThe number of ventilator-free days
Assess the efficacy of a systematic, pre-operative VA-ECMO strategy on increasing ventilator-free days in the 28 days following LT
Time frame: The 28 days following LT
The occurrence of grade III PGD
Time frame: The 72 hours following LT
All-cause mortality
Time frame: Day-90 after LT
Vital status
Time frame: Day-90 after LT
Time-to-death from all causes
Time frame: The first year after LT
The occurrence of ECMO-associated adverse event ; ECMO-associated adverse event defined as cannula infection, misplacement, intra-operative or per-ECMO air-embolism, limb ischemia, vascular complications, thrombophlebitis
Time frame: The 28 days following LT, Assessed daily from day-1 to day-90
The occurrence of ventilator associated pneumonia (VAP) ; Occurrence of VAP (microbiologically confirmed pneumonia occurring under invasive ventilation 21 and after 48 hours of invasive ventilation)
Time frame: The 28 days following LT
The occurrence of intraoperative hemodynamic failure;
Intra-operative amount of norepinephrine (dose in microg/kg of body weight)
Time frame: The 28 days following LT
The occurrence of post-operative hemodynamic failure ;
Norepinephrine-free days (number of days without noradrenaline administration)
Time frame: The 28 days following LT
The occurrence of acute renal failure;
Renal failure KDIGO stage 3
Time frame: The 28 days following LT
The need of red blood cell transfusion
Number of red blood cell packs administered
Time frame: The 28 days following LT
ECMO-free days ; VV or VA-ECMO-free days
Time frame: The 28 days following LT
The length of intensive care unit stay
Length of ICU stay in days
Time frame: at day 90
The length of hospital stay; Length of hospital stay in days
Time frame: at day 90
The occurrence of bronchial complication requiring a bronchoscopic intervention ; Bronchial complications requiring a bronchoscopic intervention
Time frame: From LT to 1-year
Forced expiratory volume during the first second (FEV1)
Time frame: At 1-year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.