Identifying Optimal PEEP After Lung Transplantation (PEEP-LuTX)

Policlinico Hospital

Status: Completed

Conditions: Primary Graft Dysfunction; Lung Transplant; Complications

Treatments: Other: PEEP

Study type: Interventional

Funder types: Other

Identifiers

NCT05691205

0058711-U

Details and patient eligibility

About

Lung Transplantation (LuTX) is the curative treatment for selected patients with end-stage lung disease. Primary Graft Dysfunction (PGD), a specific form of respiratory failure occurring within the first 72 hours after graft reperfusion, represents the most common complication after LuTX.

Actual recommendation regarding management of mechanical ventilation of the lung graft immediately after LuTX are based only on opinion experts and not on clinical trials. Optimization of Positive End-Expiratory Pressure might contribute to both prevention and treatment of PGD.

In this interventional single-center non-pharmacological study (with medical device), in the immediate postoperative period of patients who are undergone LuTX, we will evaluate the effects of varying levels of PEEP upon: - lung and chest wall mechanics, - intrapulmonary shunt fraction; - distribution of ventilation and perfusion; - gas exchange.

The final aim is to find the optimal level of PEEP in this patient's cohort

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recipient of LUTX
• Age > 18 years
• Signed informed consent

Exclusion criteria

• Age < 18 years
• Already undergone LUTX
• Major hemodynamic instability along the 24 hours following LUTX: systolic arterial pressure < 90 mmHg and/or heart rate > 120 beat/min and/or high dose vasopressor requirement (norepinephrine > 0.3 mcg/kg/min and/or epinephrine > 0.2 mcg/kg/min and/or dobutamine > 8mcg/kg/min)
• Documented post-LUTX endobronchial plasma leak requiring high levels of PEEP > 15 cmH2O

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

PEEP-LuTX

Experimental group

Description:

Within 48h after LuTX we will evaluate the effects of three levels of PEEP (14\>10\>6 cmH2O) upon: - lung and chest wall mechanics, - intrapulmonary shunt fraction; - distribution of ventilation and perfusion; - gas exchange.

Treatment:

Other: PEEP