Routine Versus Selective Intraoperative ECMO in Lung Transplant

Summary

Intraoperative hemodynamic management is vital in the success of lung transplantation. Significant intraoperative hemodynamic compromise and hypoxic episodes may contribute to an increase in severe postoperative complications related to hypoperfusion, including cerebrovascular accidents, acute kidney injury, and mesenteric ischemia. In certain lung transplant recipients, intraoperative cardiopulmonary support is mandatory because certain factors would make "off-pump" transplants unsafe. These include severe pulmonary hypertension or severe ventricular dysfunction. In such patients, routine intraoperative support should be employed. However, it is possible to conduct the lung transplant without cardiopulmonary support in the remainder of patients who do not have severe pulmonary hypertension or right heart dysfunction. In such patients, the lung transplant may be started without cardiopulmonary support. However, cardiopulmonary support may be initiated "on-demand" if there is development or impending hemodynamic embarrassment or hypoxia. Conversely, the opposite approach would be to routinely conduct all lung transplant operations using cardiopulmonary support, which may also lead to specific ECMO-related complications.

The investigators question whether on demand intraoperative ECMO in patients with significant risk factors will produce severe postoperative complications in a rate similar to routine ECMO.

Conditions

• Lung Transplant; Complications
• Extracorporeal Circulation; Complications
• Postoperative Complications

Interventions

DEVICE

Routine ECMO

Routine ECMO during lung tansplant

DEVICE

On demand ECMO

Selective, indication-based intraoperative cardiopulmonary support. In this group, the transplant will be planned without cardiopulmonary support. intraoperative ECMO will be used selectively based on hemodynamic and/or gas exchange abnormalities : 1. Inability to maintain adequate hemodynamics and stable perfusion or oxygenation during surgery 2. Prolonged high dose pressor required to maintain adequate perfusion 3. A sustained drop in cerebral saturation \> 25% of baseline despite initial attempts at optimization 4. Inability to tolerate pulmonary artery clamping 5. Inadequate gas exchange despite attempts at the optimization of ventilator parameters and treatments related to respiratory mechanics and ventilation/perfusion matching 6. Inadequate exposure to the surgical field

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM)

  lead OTHER

Principal Investigators

• Basil Nasir, MD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-15

Primary Completion

2023-03-15

Completion

2023-12-15

Countries

• Canada

Study Locations