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NCT Number: NCT05691205

Identifying Optimal PEEP After Lung Transplantation

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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Key information

Conditions

Lung Transplant; Complications Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Primary Graft Dysfunction Reperfusion Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, 20122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEP

Other

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

Primary outcomes

  1. Lung Compliance

    Time frame: Measurements at three PEEP levels during a decremental PEEP trial

    Identifying the level of PEEP associated to the best compliance

Secondary outcomes

  1. Lung collapse&overdistension

    Time frame: 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

  2. Lung perfusion

    Time frame: 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

  3. Intrapulmonary shunt

    Time frame: Measurements at three PEEP levels during a decremental PEEP trial

    Identifying the level of PEEP associated to the lowest intrapulmonary shunt level

  4. Dead space

    Time frame: Measurements at three PEEP levels during a decremental PEEP trial

    Identifying the level of PEEP associated to the lowest dead space fraction

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Official study title

Identifying the Optimal Positive End-Expiratory Pressure Level to Ventilate Patients After Bilateral Lung Transplantation

Acronym: PEEP-LuTX

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 19, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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