PEEP-LuTX: Identifying Optimal PEEP After Lung Transplantation

• Sponsor: Policlinico Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05691205
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 39.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lung Transplant; Complications; Primary Graft Dysfunction	Other: PEEP	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Identifying the Optimal Positive End-Expiratory Pressure Level to Ventilate Patients After Bilateral Lung Transplantation
• Anticipated Study Start Date: Jan 31, 2023
• Anticipated Primary Completion Date: Jan 31, 2025
• Anticipated Study Completion Date: May 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: PEEP; After a recruitment maneuver three levels of PEEP (14>10>6cmH2O) will be tested

Outcome Measures

Primary Outcome Measures

1. Lung Compliance [Measurements at three PEEP levels during a decremental PEEP trial]

   Identifying the level of PEEP associated to the best compliance

Secondary Outcome Measures

1. Lung collapse&overdistension [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 [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 [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 [Measurements at three PEEP levels during a decremental PEEP trial]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico	Milan		Italy	20122

Sponsors and Collaborators

• Policlinico Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Giacomo Grasselli, Professor, Policlinico Hospital
• ClinicalTrials.gov Identifier: NCT05691205
• Other Study ID Numbers: 0058711-U
• First Posted: Jan 19, 2023
• Last Update Posted: Jan 19, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Giacomo Grasselli, Professor, Policlinico Hospital: Lung Transplantation; Primary Graft Dysfunction; Mechanical Ventilation; Positive End-Expiratory Pressure; Electrical Impedance Tomography
• Additional relevant MeSH terms: Primary Graft Dysfunction

Study Results

No Results Posted as of Jan 19, 2023