Lung Transplant; ComplicationsPEEP-LuTXNCT05691205
Identifying Optimal PEEP After Lung Transplantation
A study testing PEEP in people with Lung Transplant; Complications and Primary Graft Dysfunction, run by Policlinico Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant; Complications, Primary Graft Dysfunction
- What is being tested?
- PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jan 2023to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient of LUTX
- Age > 18 years
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
Milan, Milan, 20122
About this study
Official title: Identifying the Optimal Positive End-Expiratory Pressure Level to Ventilate Patients After Bilateral Lung Transplantation
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.
Read more
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
- Being tested
- PEEP
- Keywords
- Lung Transplantation, Primary Graft Dysfunction, Mechanical Ventilation, Positive End-Expiratory Pressure, Electrical Impedance Tomography
- Medical subject headings
- Primary Graft Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPOther
After a recruitment maneuver three levels of PEEP (14>10>6cmH2O) will be tested
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Compliance
Identifying the level of PEEP associated to the best compliance
Measured: Measurements at three PEEP levels during a decremental PEEP trial
Secondary outcomes (4)
Lung collapse&overdistension
Identifying the level of PEEP associated to the lowest collapse\&overdistension according to Electrical Impedance Tomography
Measured: Measurements at three PEEP levels during a decremental PEEP trial
Lung perfusion
Identifying the level of PEEP associated to the most homogeneous distribution of lung perfusion according to Electrical Impedance Tomography
Measured: Measurements at three PEEP levels during a decremental PEEP trial
Intrapulmonary shunt
Identifying the level of PEEP associated to the lowest intrapulmonary shunt level
Measured: Measurements at three PEEP levels during a decremental PEEP trial
Dead space
Identifying the level of PEEP associated to the lowest dead space fraction
Measured: Measurements at three PEEP levels during a decremental PEEP trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start31 Jan 2023
- Primary completion31 Dec 2024
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Grasselli, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691205
- Sponsor's protocol ID
- 0058711-U
- Acronym
- PEEP-LuTX
- Status last verified
- Mar 2025
- First submitted
- 11 Jan 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified data will be shared with other researchers upon explicit request
Publications
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.
PubMed 23306540Talmor 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.
PubMed 19001507Costa 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.
PubMed 19255741
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Optimal Positive End-Expiratory Pressure Level to Ventilate Patients After Bilateral Lung Transplantation
- ClinicalTrials.gov ID
- NCT05691205
- Acronym / sponsor ID
- PEEP-LuTX / 0058711-U
- Keywords
- Lung Transplantation, Primary Graft Dysfunction, Mechanical Ventilation, Positive End-Expiratory Pressure, Electrical Impedance Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEEP-LuTX | Experimental | Other: PEEPWithin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recipient of LUTX
- Age > 18 years
- Signed informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEPAfter a recruitment maneuver three levels of PEEP (14>10>6cmH2O) will be tested | Other | PEEP-LuTX |
Primary outcome
Lung Compliance
Time frame: Measurements at three PEEP levels during a decremental PEEP trial
Identifying the level of PEEP associated to the best compliance
4 secondary outcomes
Lung collapse&overdistension
Time frame: Measurements at three PEEP levels during a decremental PEEP trial
Lung perfusion
Time frame: Measurements at three PEEP levels during a decremental PEEP trial
Intrapulmonary shunt
Time frame: Measurements at three PEEP levels during a decremental PEEP trial
Dead space
Time frame: Measurements at three PEEP levels during a decremental PEEP trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 23306540Diamond 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.
- Background: PubMed 19001507Talmor 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.
- Background: PubMed 19255741Costa 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.
- Individual participant dataSharing planned: Undecided. Deidentified data will be shared with other researchers upon explicit request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP in people with Lung Transplant; Complications and Primary Graft Dysfunction, run by Policlinico Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Compliance (time frame: Measurements at three PEEP levels during a decremental PEEP trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05691205, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.