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Identifying Optimal PEEP After Lung Transplantation (PEEP-LuTX)

Primary Purpose

Lung Transplant; Complications, Primary Graft Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PEEP
Sponsored by
Policlinico Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Transplant; Complications focused on measuring Lung Transplantation, Primary Graft Dysfunction, Mechanical Ventilation, Positive End-Expiratory Pressure, Electrical Impedance Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione IRCCS Ca'Granda - Ospedale Maggiore PoliclinicoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEEP-LuTX

Arm Description

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.

Outcomes

Primary Outcome Measures

Lung Compliance
Identifying the level of PEEP associated to the best compliance

Secondary Outcome Measures

Lung collapse&overdistension
Identifying the level of PEEP associated to the lowest collapse&overdistension according to Electrical Impedance Tomography
Lung perfusion
Identifying the level of PEEP associated to the most homogeneous distribution of lung perfusion according to Electrical Impedance Tomography
Intrapulmonary shunt
Identifying the level of PEEP associated to the lowest intrapulmonary shunt level
Dead space
Identifying the level of PEEP associated to the lowest dead space fraction

Full Information

First Posted
January 11, 2023
Last Updated
April 4, 2023
Sponsor
Policlinico Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05691205
Brief Title
Identifying Optimal PEEP After Lung Transplantation
Acronym
PEEP-LuTX
Official Title
Identifying the Optimal Positive End-Expiratory Pressure Level to Ventilate Patients After Bilateral Lung Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
May 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplant; Complications, Primary Graft Dysfunction
Keywords
Lung Transplantation, Primary Graft Dysfunction, Mechanical Ventilation, Positive End-Expiratory Pressure, Electrical Impedance Tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEEP-LuTX
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PEEP
Intervention Description
After a recruitment maneuver three levels of PEEP (14>10>6cmH2O) will be tested
Primary Outcome Measure Information:
Title
Lung Compliance
Description
Identifying the level of PEEP associated to the best compliance
Time Frame
Measurements at three PEEP levels during a decremental PEEP trial
Secondary Outcome Measure Information:
Title
Lung collapse&overdistension
Description
Identifying the level of PEEP associated to the lowest collapse&overdistension according to Electrical Impedance Tomography
Time Frame
Measurements at three PEEP levels during a decremental PEEP trial
Title
Lung perfusion
Description
Identifying the level of PEEP associated to the most homogeneous distribution of lung perfusion according to Electrical Impedance Tomography
Time Frame
Measurements at three PEEP levels during a decremental PEEP trial
Title
Intrapulmonary shunt
Description
Identifying the level of PEEP associated to the lowest intrapulmonary shunt level
Time Frame
Measurements at three PEEP levels during a decremental PEEP trial
Title
Dead space
Description
Identifying the level of PEEP associated to the lowest dead space fraction
Time Frame
Measurements at three PEEP levels during a decremental PEEP trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vittorio Scaravilli
Phone
+390255033275
Email
vittorio.scaravilli@gmail.com
Facility Information:
Facility Name
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vittorio Scaravilli, MD
Email
vittorio.scaravilli@unimi.it
First Name & Middle Initial & Last Name & Degree
Vittorio Scaravilli, MD
First Name & Middle Initial & Last Name & Degree
Jacopo Fumagalli, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Deidentified data will be shared with other researchers upon explicit request
Citations:
PubMed Identifier
23306540
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.
Results Reference
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PubMed Identifier
19001507
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.
Results Reference
background
PubMed Identifier
19255741
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.
Results Reference
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Identifying Optimal PEEP After Lung Transplantation

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