Clinical trial NCT05691205: Identifying Optimal PEEP After Lung Transplantation
Official title: Identifying the Optimal Positive End-Expiratory Pressure Level to Ventilate Patients After Bilateral Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplant; Complications
Primary Graft Dysfunction
Keywords: Lung Transplantation
Primary Graft Dysfunction
Mechanical Ventilation
Positive End-Expiratory Pressure
Electrical Impedance Tomography
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Lung Compliance
timeFrame: Measurements at three PEEP levels during a decremental PEEP trial
Secondary outcomes:
measure: Lung collapse&overdistension
timeFrame: Measurements at three PEEP levels during a decremental PEEP trial
measure: Lung perfusion
timeFrame: Measurements at three PEEP levels during a decremental PEEP trial
measure: Intrapulmonary shunt
timeFrame: Measurements at three PEEP levels during a decremental PEEP trial
measure: Dead space
timeFrame: Measurements at three PEEP levels during a decremental PEEP trial
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
Study officials:
References:
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.
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.
citation: 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.