Identifying Optimal PEEP After Lung Transplantation

NCT05691205 | Completed

• 1 other identifier: 0058711-U
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Transplant; Complications; Primary Graft Dysfunction

Keywords

Lung Transplantation; Primary Graft Dysfunction; Mechanical Ventilation; Positive End-Expiratory Pressure; Electrical Impedance Tomography

Outcome Measures

Primary Outcomes (1)

• Lung Compliance

  Identifying the level of PEEP associated to the best compliance

  Measurements at three PEEP levels during a decremental PEEP trial

Secondary Outcomes (4)

• Lung collapse&overdistension

  Measurements at three PEEP levels during a decremental PEEP trial

• Lung perfusion

  Measurements at three PEEP levels during a decremental PEEP trial

• Intrapulmonary shunt

  Measurements at three PEEP levels during a decremental PEEP trial

• Dead space

  Measurements at three PEEP levels during a decremental PEEP trial

Study Arms (1)

PEEP-LuTX

EXPERIMENTAL

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.

Other: PEEP

Interventions

PEEP OTHER

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

PEEP-LuTX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Policlinico Hospital: lead

Study Sites (1)

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, Milan, 20122, Italy

Location

Related Publications (3)

• Diamond JM, Lee JC, Kawut SM, Shah RJ, Localio AR, Bellamy SL, Lederer DJ, Cantu E, Kohl BA, Lama VN, Bhorade SM, Crespo M, Demissie E, Sonett J, Wille K, Orens J, Shah AS, Weinacker A, Arcasoy S, Shah PD, Wilkes DS, Ware LB, Palmer SM, Christie JD; Lung Transplant Outcomes Group. Clinical risk factors for primary graft dysfunction after lung transplantation. Am J Respir Crit Care Med. 2013 Mar 1;187(5):527-34. doi: 10.1164/rccm.201210-1865OC. Epub 2013 Jan 10.

  PMID: 23306540 BACKGROUND

• Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.

  PMID: 19001507 BACKGROUND

• Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.

  PMID: 19255741 BACKGROUND

MeSH Terms

Conditions

Primary Graft Dysfunction

Condition Hierarchy (Ancestors)

Reperfusion Injury; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 19, 2023
• Study Start: January 31, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 15, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

IT (1)