Identifying Optimal PEEP After Lung Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-03-15

Brief Summary

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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

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Detailed Description

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Conditions

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Lung Transplant; Complications Primary Graft Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PEEP-LuTX

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.

Group Type EXPERIMENTAL

PEEP

Intervention Type OTHER

After a recruitment maneuver three levels of PEEP (14\>10\>6cmH2O) will be tested

Interventions

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PEEP

After a recruitment maneuver three levels of PEEP (14\>10\>6cmH2O) will be tested

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No