Identifying Optimal PEEP After Lung Transplantation

Not Applicable

Completed

• Conditions: Primary Graft Dysfunction; Lung Transplant; Complications
• Interventions: Other: PEEP

• Registration Number: NCT05691205
• Lead Sponsor: Policlinico Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-19
• Study Start: 2023-01-31
• Primary Completion: 2024-12-31
• Status Verified: 2025-03
• Study Completion: 2025-03-15
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEEP-LuTX	PEEP	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.

Primary Outcome Measures

Name	Time	Method
Lung Compliance	Measurements at three PEEP levels during a decremental PEEP trial	Identifying the level of PEEP associated to the best compliance

Secondary Outcome Measures

Name	Time	Method
Intrapulmonary shunt	Measurements at three PEEP levels during a decremental PEEP trial	Identifying the level of PEEP associated to the lowest intrapulmonary shunt level
Lung collapse&overdistension	Measurements at three PEEP levels during a decremental PEEP trial	Identifying the level of PEEP associated to the lowest collapse\&overdistension according to Electrical Impedance Tomography
Dead space	Measurements at three PEEP levels during a decremental PEEP trial	Identifying the level of PEEP associated to the lowest dead space fraction
Lung perfusion	Measurements at three PEEP levels during a decremental PEEP trial	Identifying the level of PEEP associated to the most homogeneous distribution of lung perfusion according to Electrical Impedance Tomography

Trial Locations

Locations (1)

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy