Lung TransplantNCT06159933
Primary Graft Dysfunction, Pronation, Bilateral Lung Transplants
A study testing Supine positioning, Early pronation and Late pronation in people with Lung Transplant and Primary Graft Dysfunction, run by University of Padova at 1 site in Italy.
Trial summary
Proning manoeuvre as an early treatment for acute severe hypoxic respiratory failure has been implemented recently during the COVID-19 pandemic. This method was proposed more than fifty years ago to improve gas exchange : Proning Severe ARDS (PROSEVA) trial, however, was the milestone which demonstrated mortality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant, Primary Graft Dysfunction
- What is being tested?
- Supine positioning, Early pronation and Late pronation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 15 Nov 2023
- 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
- Age > 18 y.o.
- First bilateral lung transplant
- PGD grade 2 or 3 within 24 hours from ICU admission Admission to ICU for post-operative monitoring after LTx
- Written informed consent obtained
Who cannot join
- Age < 18 years old
- PGD<2
- Single transplant
- Re-transplant
- IMV, venous-venous (V-V) or venous-arterial (V-A) extracorporeal membrane oxygenation (ECMO) before surgery
- Contraindications to prone positioning
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Prone Positioning as a Rescue Therapy for Severe Primary Graft Dysfunction After Bilateral Lung Transplant.
Proning manoeuvre as an early treatment for acute severe hypoxic respiratory failure has been implemented recently during the COVID-19 pandemic. This method was proposed more than fifty years ago to improve gas exchange : Proning Severe ARDS (PROSEVA) trial, however, was the milestone which demonstrated mortality benefit in patients with severe ARDS. Nevertheless, few analysis were performed on the effects of the prone position after lung transplantion (LT). The aim of the study is therefore to relate LT primary graft dysfunction (PGD) pathophysiology, which occurs in postoperative setting, to prone-positioning effects on ventilation-perfusion matching, improved lung compliance and clinical outcomes of impairedorgan patients.
Read the detailed description
Lung transplant is the final stage of intervention in dramatic respiratory failure unresponsive to other medical or surgical treatments: reduced disability, improved life quality and extended life are outweighed by still high mortality and morbidity of LT, compared to other solid organs transplants. LT patient survival is undermined, above all, by PGD onset up to 72h in postoperative scenario. Acute lung injury, characterized by reperfusion and ischemia damage, evolves in pulmonary edema and severely inflammed graft status. Tipical radiological findings are bilateral spreading infiltrates, whose treatment was until some years ago mainly supportive, i.e. protective mechanical ventilation and fluid restriction. Two retrospective studies recently demonstrated favorable oxygenation response in terms of PaO2/fraction-of-inspired-oxygen (FiO2) ratio and lung compliance. Our purpose was to broaden gas-exchange results by the analysis of short-term outcomes (i.e duration of mechanical ventilation, reintubation or tracheostomy, anastomotical complications, organ rejection in 30 days, acute kindney injury development and/or filtration necessity, hospital length and mortality). Our aim is to assess through this pilot study if early pronation (realized within 24 hours from admission) has a more favorable outcome on patients developing moderate/severe PGD within the first 24 postoperative hours.
- Conditions
- Lung Transplant, Primary Graft Dysfunction
- Being tested
- Supine positioning, Early pronation, Late pronation
- Keywords
- pronation, end-stage lung disease
- 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.
Supine positioningProcedure or surgery
According to our local protocol, until December 2021, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group).
Early pronationProcedure or surgery
According to our local protocol, starting from January 2022, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group).
Late pronationProcedure or surgery
According to our local protocol, until December 2021, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group).
| Study group | Role | What they receive |
|---|---|---|
| Historic cohort (SUPINE POSITIONING) | Experimental | According to our local protocol, until December 2021, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group). Receives: Procedure: Supine positioning |
| Historic cohort (LATE PRONATION) | Experimental | According to our local protocol, until December 2021, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group). Receives: Procedure: Late pronation |
| Prospective cohort (EARLY PRONATION) | Experimental | On the contrary, starting from January 2022 our local protocol was updated and all LT recipients developing PGD >1 were routinely turned prone within 24 hours after the diagnosis ('early PP').Patients were placed in PP for at least 16 hours before being turned back to the supine position when meeting predefined criteria previously published by Guèrin et al Receives: Procedure: Early pronation |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day ventilator free days
Days free from invasive mechanical ventilation after lung transplant
Measured: From ICU admission up to 28 post-operative days (POD)
Secondary outcomes (2)
Invasive mechanical ventilation (IMV)
Duration of IMV
Measured: From ICU adminission up to liberation from invasive mechanical ventilation
Blood gas exchanges (PaO2 /FiO2 PaCo2, pH)
Emogas analysis
Measured: Within 24hours from ICU admission, at 72 hours later, in supine and prone position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Jan 2020
- Primary completion30 Apr 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Historic cohort enrolled between January 2020 and December 2021; Prospective enrollment from January 2022 to April 2023. According to our local protocol, until December 2021, all patients developing PGD \>1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group). On the contrary, starting from January 2022 our local protocol was updated and all LT recipients developing PGD \>1 were routinely turned prone within 24 hours after the diagnosis ('early PP').Patients were placed in PP for at least 16 hours before being turned back to the supine position when meeting predefined criteria previously published by Guèrin et al.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annalisa Boscolo, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159933
- Sponsor's protocol ID
- reference 4539/AO/18
- Status last verified
- Jan 2024
- First submitted
- 28 Nov 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prone Positioning as a Rescue Therapy for Severe Primary Graft Dysfunction After Bilateral Lung Transplant.
- ClinicalTrials.gov ID
- NCT06159933
- Acronym / sponsor ID
- reference 4539/AO/18
- Conditions
- Lung Transplant, Primary Graft Dysfunction
- Keywords
- pronation, end-stage lung disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 7 Dec 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.
Proning manoeuvre as an early treatment for acute severe hypoxic respiratory failure has been implemented recently during the COVID-19 pandemic. This method was proposed more than fifty years ago to improve gas exchange : Proning Severe ARDS (PROSEVA) trial, however, was the milestone which demonstrated mortality benefit in patients with severe ARDS. Nevertheless, few analysis were performed on the effects of the prone position after lung transplantion (LT). The aim of the study is therefore to relate LT primary graft dysfunction (PGD) pathophysiology, which occurs in postoperative setting, to prone-positioning effects on ventilation-perfusion matching, improved lung compliance and clinical outcomes of impairedorgan patients.
Detailed description
Lung transplant is the final stage of intervention in dramatic respiratory failure unresponsive to other medical or surgical treatments: reduced disability, improved life quality and extended life are outweighed by still high mortality and morbidity of LT, compared to other solid organs transplants. LT patient survival is undermined, above all, by PGD onset up to 72h in postoperative scenario. Acute lung injury, characterized by reperfusion and ischemia damage, evolves in pulmonary edema and severely inflammed graft status. Tipical radiological findings are bilateral spreading infiltrates, whose treatment was until some years ago mainly supportive, i.e. protective mechanical ventilation and fluid restriction. Two retrospective studies recently demonstrated favorable oxygenation response in terms of PaO2/fraction-of-inspired-oxygen (FiO2) ratio and lung compliance. Our purpose was to broaden gas-exchange results by the analysis of short-term outcomes (i.e duration of mechanical ventilation, reintubation or tracheostomy, anastomotical complications, organ rejection in 30 days, acute kindney injury development and/or filtration necessity, hospital length and mortality). Our aim is to assess through this pilot study if early pronation (realized within 24 hours from admission) has a more favorable outcome on patients developing moderate/severe PGD within the first 24 postoperative hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Historic cohort enrolled between January 2020 and December 2021; Prospective enrollment from January 2022 to April 2023. According to our local protocol, until December 2021, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group). On the contrary, starting from January 2022 our local protocol was updated and all LT recipients developing PGD >1 were routinely turned prone within 24 hours after the diagnosis ('early PP').Patients were placed in PP for at least 16 hours before being turned back to the supine position when meeting predefined criteria previously published by Guèrin et al.
| Arm | Type | Receives |
|---|---|---|
| Historic cohort (SUPINE POSITIONING) | Experimental | Procedure: Supine positioningAccording to our local protocol, until December 2021, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group). |
| Historic cohort (LATE PRONATION) | Experimental | Procedure: Late pronationAccording to our local protocol, until December 2021, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group). |
| Prospective cohort (EARLY PRONATION) | Experimental | Procedure: Early pronationOn the contrary, starting from January 2022 our local protocol was updated and all LT recipients developing PGD >1 were routinely turned prone within 24 hours after the diagnosis ('early PP').Patients were placed in PP for at least 16 hours before being turned back to the supine position when meeting predefined criteria previously published by Guèrin et al |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 y.o.
- First bilateral lung transplant
- PGD grade 2 or 3 within 24 hours from ICU admission Admission to ICU for post-operative monitoring after LTx
- Written informed consent obtained
Key exclusion criteria (7 listed)
- Age < 18 years old
- PGD<2
- Single transplant
- Re-transplant
- IMV, venous-venous (V-V) or venous-arterial (V-A) extracorporeal membrane oxygenation (ECMO) before surgery
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 |
|---|---|---|
| Supine positioningAccording to our local protocol, until December 2021, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group). | Procedure or surgery | Historic cohort (SUPINE POSITIONING) |
| Early pronationAccording to our local protocol, starting from January 2022, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group). | Procedure or surgery | Prospective cohort (EARLY PRONATION) |
| Late pronationAccording to our local protocol, until December 2021, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group). | Procedure or surgery | Historic cohort (LATE PRONATION) |
Primary outcome
28-day ventilator free days
Time frame: From ICU admission up to 28 post-operative days (POD)
Days free from invasive mechanical ventilation after lung transplant
2 secondary outcomes
Invasive mechanical ventilation (IMV)
Time frame: From ICU adminission up to liberation from invasive mechanical ventilation
Blood gas exchanges (PaO2 /FiO2 PaCo2, pH)
Time frame: Within 24hours from ICU admission, at 72 hours later, in supine and prone position
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 1 Feb 2024.
- Individual participant dataSharing planned: No
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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 Supine positioning, Early pronation and Late pronation in people with Lung Transplant and Primary Graft Dysfunction, run by University of Padova 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 4 inclusion and 7 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 1 Feb 2024. 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?
28-day ventilator free days (time frame: From ICU admission up to 28 post-operative days (POD)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2024.