Identifying Optimal PEEP After Lung Transplantation

Lung Transplant; Complications Clinical Trial

— PEEP-LuTX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691205
• Other study ID #: 0058711-U
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: May 30, 2026

Study information

• Verified date: April 2023
• Source: Policlinico Hospital
• Contact: Vittorio Scaravilli
• Phone: +390255033275
• Email: vittorio.scaravilli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 30, 2026
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant; Complications
• Primary Graft Dysfunction

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Compliance	Identifying the level of PEEP associated to the best compliance	Measurements at three PEEP levels during a decremental PEEP trial
Secondary	Lung collapse&overdistension	Identifying the level of PEEP associated to the lowest collapse&overdistension according to Electrical Impedance Tomography	Measurements at three PEEP levels during a decremental PEEP trial
Secondary	Lung perfusion	Identifying the level of PEEP associated to the most homogeneous distribution of lung perfusion according to Electrical Impedance Tomography	Measurements at three PEEP levels during a decremental PEEP trial
Secondary	Intrapulmonary shunt	Identifying the level of PEEP associated to the lowest intrapulmonary shunt level	Measurements at three PEEP levels during a decremental PEEP trial
Secondary	Dead space	Identifying the level of PEEP associated to the lowest dead space fraction	Measurements at three PEEP levels during a decremental PEEP trial