Lung Transplant FailureNCT06202859
Respiratory Physiotherapy as a Tool to Increase the Number of Solid Organ Donors
A study testing MIE in people with Lung Transplant Failure, run by Vall d'Hebron Institute Research at 1 site in Spain.
Trial summary
The main objective of the project is to determine the variation of PaO2 / FiO2 (PaFi) after the use of mechanical insufflation-exsufflation (MI-E) or mechanical cough assistant in the donor in brain death (DBD) and in the potential donor in control donor after circulatory death (cDCD) It is a randomized prospective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Failure
- What is being tested?
- MIE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2022to Apr 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
- Organ donor older than 18yo
Who cannot join
- Absolute contraindications for MIE's use
- Absolute contraindications for organ donation
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Irene bello
Barcelona, 08024
Irene bello, Prof, 620664172, irene.bello.rodriguez@gmail.com
About this study
The main objective of the project is to determine the variation of PaO2 / FiO2 (PaFi) after the use of mechanical insufflation-exsufflation (MI-E) or mechanical cough assistant in the donor in brain death (DBD) and in the potential donor in control donor after circulatory death (cDCD) It is a randomized prospective multicentre study. Four centres with a solid organ donation program will participate in the study, the Hospital Clínic i Provincial de Barcelona (HCB), the Germans Tries y Pujol Hospital (HGTP), the Marqués de Valdecilla Hospital (HMV) and the Vall d'Hebron Hospital (HVH). One hundred and sixty consecutive eligible donors will be included in DBD and cDCD older than 18 years.
- P1: Eighty donors will be maintained following national guidelines.
- P2: Eighty donors will be maintained following national guidelines and:
- Manual techniques of secretion drainage
- Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips.
Demographic variables of the donor and recipient will be collected, as well as differences in PaFi, static compliance, and radiographic changes between P1 and P2 donors. The percentage of lung donors recovered by P2 with respect to P1 will be analyzed.
- Conditions
- Lung Transplant Failure
- Being tested
- MIE
- Keywords
- respiratory physiotherapy, lung donor, improve lung donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIEDevice
Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips.
| Study group | Role | What they receive |
|---|---|---|
| MIE group | Experimental | * Manual techniques of secretion drainage
* Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips. Receives: Device: MIE |
| Control group | Active comparator | Maintained following national guidelines. Receives: Device: MIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in Oxygenation
The changes of oxygenation comparing MIE to national protocol
Measured: Ten minutes after the MIE application and 60 minutes after MIE application or national protocol aplication
Secondary outcomes (3)
Rate of complications with the use of MIE
To analyse the complications associated with the use of MIE in organ donors
Measured: During the intervention and 60 minutes after it.
Number of potential lung donors
To analyse the increase in potential lung donors with MIE
Measured: during the recruitment time
Number of lung donors
To analyse the increase in lung donors with MIE
Measured: during the recruitment time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Nov 2022
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant FailureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vall d'Hebron Institute Research
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Germans Trias i Pujol Hospital, Hospital Universitario Marqués de Valdecilla
- Responsible party
- Principal investigator, Irene Bello, Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Investigators
- Irene bello, Professor, Study chair, Vall d'Hebron Institute Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202859
- Sponsor's protocol ID
- MIE-don study
- Status last verified
- Jan 2024
- First submitted
- 23 Oct 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Stiller K. Physiotherapy in intensive care: an updated systematic review. Chest. 2013 Sep;144(3):825-847. doi: 10.1378/chest.12-2930.
PubMed 23722822Battaglini D, Robba C, Caiffa S, Ball L, Brunetti I, Loconte M, Giacobbe DR, Vena A, Patroniti N, Bassetti M, Torres A, Rocco PR, Pelosi P. Chest physiotherapy: An important adjuvant in critically ill mechanically ventilated patients with COVID-19. Respir Physiol Neurobiol. 2020 Nov;282:103529. doi: 10.1016/j.resp.2020.103529. Epub 2020 Aug 17.
PubMed 32818606Thomas P, Baldwin C, Bissett B, Boden I, Gosselink R, Granger CL, Hodgson C, Jones AY, Kho ME, Moses R, Ntoumenopoulos G, Parry SM, Patman S, van der Lee L. Physiotherapy management for COVID-19 in the acute hospital setting: clinical practice recommendations. J Physiother. 2020 Apr;66(2):73-82. doi: 10.1016/j.jphys.2020.03.011. Epub 2020 Mar 30.
PubMed 32312646Fernandez-Carmona A, Olivencia-Pena L, Yuste-Ossorio ME, Penas-Maldonado L; Grupo de Trabajo de Unidad de Ventilacion Mecanica Domiciliaria de Granada. Ineffective cough and mechanical mucociliary clearance techniques. Med Intensiva (Engl Ed). 2018 Jan-Feb;42(1):50-59. doi: 10.1016/j.medin.2017.05.003. Epub 2017 Jun 12. English, Spanish.
PubMed 28619528Ferreira de Camillis ML, Savi A, Goulart Rosa R, Figueiredo M, Wickert R, Borges LGA, Galant L, Teixeira C. Effects of Mechanical Insufflation-Exsufflation on Airway Mucus Clearance Among Mechanically Ventilated ICU Subjects. Respir Care. 2018 Dec;63(12):1471-1477. doi: 10.4187/respcare.06253. Epub 2018 Jul 17.
PubMed 30018175Lachal R, Louis B, Subtil F, Guerin C. Bench Assessment of the Effect of a Collapsible Tube on the Efficiency of a Mechanical Insufflation-Exsufflation Device. Respir Care. 2019 Jul;64(7):752-759. doi: 10.4187/respcare.06478. Epub 2019 Mar 12.
PubMed 30862688Morrow B, Zampoli M, van Aswegen H, Argent A. Mechanical insufflation-exsufflation for people with neuromuscular disorders. Cochrane Database Syst Rev. 2013 Dec 30;(12):CD010044. doi: 10.1002/14651858.CD010044.pub2.
PubMed 24374746Sanchez-Garcia M, Santos P, Rodriguez-Trigo G, Martinez-Sagasti F, Farina-Gonzalez T, Del Pino-Ramirez A, Cardenal-Sanchez C, Busto-Gonzalez B, Requesens-Solera M, Nieto-Cabrera M, Romero-Romero F, Nunez-Reiz A. Preliminary experience on the safety and tolerability of mechanical "insufflation-exsufflation" in subjects with artificial airway. Intensive Care Med Exp. 2018 Apr 3;6(1):8. doi: 10.1186/s40635-018-0173-6.
PubMed 29616357Bach JR. Noninvasive Respiratory Management of Patients With Neuromuscular Disease. Ann Rehabil Med. 2017 Aug;41(4):519-538. doi: 10.5535/arm.2017.41.4.519. Epub 2017 Aug 31.
PubMed 28971036Guerin C, Bourdin G, Leray V, Delannoy B, Bayle F, Germain M, Richard JC. Performance of the coughassist insufflation-exsufflation device in the presence of an endotracheal tube or tracheostomy tube: a bench study. Respir Care. 2011 Aug;56(8):1108-14. doi: 10.4187/respcare.01121.
PubMed 21801577Volpe MS, Naves JM, Ribeiro GG, Ruas G, Amato MBP. Airway Clearance With an Optimized Mechanical Insufflation-Exsufflation Maneuver. Respir Care. 2018 Oct;63(10):1214-1222. doi: 10.4187/respcare.05965. Epub 2018 Jul 17.
PubMed 30018177Bach JR, Saporito LR, Shah HR, Sinquee D. Decanulation of patients with severe respiratory muscle insufficiency: efficacy of mechanical insufflation-exsufflation. J Rehabil Med. 2014 Nov;46(10):1037-41. doi: 10.2340/16501977-1874.
PubMed 25096928Toussaint M. The use of mechanical insufflation-exsufflation via artificial airways. Respir Care. 2011 Aug;56(8):1217-9. doi: 10.4187/respcare.01448. No abstract available.
PubMed 21801584Rose L. Strategies for weaning from mechanical ventilation: a state of the art review. Intensive Crit Care Nurs. 2015 Aug;31(4):189-95. doi: 10.1016/j.iccn.2015.07.003. Epub 2015 Jul 21.
PubMed 26209016Goncalves MR, Honrado T, Winck JC, Paiva JA. Effects of mechanical insufflation-exsufflation in preventing respiratory failure after extubation: a randomized controlled trial. Crit Care. 2012 Dec 12;16(2):R48. doi: 10.1186/cc11249.
PubMed 22420538
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Physiotherapy as a Tool to Increase the Number of Solid Organ Donors
- ClinicalTrials.gov ID
- NCT06202859
- Acronym / sponsor ID
- MIE-don study
- Conditions
- Lung Transplant Failure
- Keywords
- respiratory physiotherapy, lung donor, improve lung donor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Vall d'Hebron Institute ResearchUniversity, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Germans Trias i Pujol Hospital, Hospital Universitario Marqués de Valdecilla
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Jan 2024 (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.
The main objective of the project is to determine the variation of PaO2 / FiO2 (PaFi) after the use of mechanical insufflation-exsufflation (MI-E) or mechanical cough assistant in the donor in brain death (DBD) and in the potential donor in control donor after circulatory death (cDCD) It is a randomized prospective multicentre study. Four centres with a solid organ donation program will participate in the study, the Hospital Clínic i Provincial de Barcelona (HCB), the Germans Tries y Pujol Hospital (HGTP), the Marqués de Valdecilla Hospital (HMV) and the Vall d'Hebron Hospital (HVH). One hundred and sixty consecutive eligible donors will be included in DBD and cDCD older than 18 years.
- P1: Eighty donors will be maintained following national guidelines.
- P2: Eighty donors will be maintained following national guidelines and:
- Manual techniques of secretion drainage
- Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips.
Demographic variables of the donor and recipient will be collected, as well as differences in PaFi, static compliance, and radiographic changes between P1 and P2 donors. The percentage of lung donors recovered by P2 with respect to P1 will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIE group | Experimental | Device: MIE* Manual techniques of secretion drainage * Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips. |
| Control group | Active comparator | Device: MIEMaintained following national guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Organ donor older than 18yo
Key exclusion criteria (2 listed)
- Absolute contraindications for MIE's use
- Absolute contraindications for organ donation
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 |
|---|---|---|
| MIETwo sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips. | Device | Control group, MIE group |
Primary outcome
The changes in Oxygenation
Time frame: Ten minutes after the MIE application and 60 minutes after MIE application or national protocol aplication
The changes of oxygenation comparing MIE to national protocol
3 secondary outcomes
Rate of complications with the use of MIE
Time frame: During the intervention and 60 minutes after it.
Number of potential lung donors
Time frame: during the recruitment time
Number of lung donors
Time frame: during the recruitment time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 23722822Stiller K. Physiotherapy in intensive care: an updated systematic review. Chest. 2013 Sep;144(3):825-847. doi: 10.1378/chest.12-2930.
- Background: PubMed 32818606Battaglini D, Robba C, Caiffa S, Ball L, Brunetti I, Loconte M, Giacobbe DR, Vena A, Patroniti N, Bassetti M, Torres A, Rocco PR, Pelosi P. Chest physiotherapy: An important adjuvant in critically ill mechanically ventilated patients with COVID-19. Respir Physiol Neurobiol. 2020 Nov;282:103529. doi: 10.1016/j.resp.2020.103529. Epub 2020 Aug 17.
- Background: PubMed 32312646Thomas P, Baldwin C, Bissett B, Boden I, Gosselink R, Granger CL, Hodgson C, Jones AY, Kho ME, Moses R, Ntoumenopoulos G, Parry SM, Patman S, van der Lee L. Physiotherapy management for COVID-19 in the acute hospital setting: clinical practice recommendations. J Physiother. 2020 Apr;66(2):73-82. doi: 10.1016/j.jphys.2020.03.011. Epub 2020 Mar 30.
- Background: PubMed 28619528Fernandez-Carmona A, Olivencia-Pena L, Yuste-Ossorio ME, Penas-Maldonado L; Grupo de Trabajo de Unidad de Ventilacion Mecanica Domiciliaria de Granada. Ineffective cough and mechanical mucociliary clearance techniques. Med Intensiva (Engl Ed). 2018 Jan-Feb;42(1):50-59. doi: 10.1016/j.medin.2017.05.003. Epub 2017 Jun 12. English, Spanish.
- Background: PubMed 30018175Ferreira de Camillis ML, Savi A, Goulart Rosa R, Figueiredo M, Wickert R, Borges LGA, Galant L, Teixeira C. Effects of Mechanical Insufflation-Exsufflation on Airway Mucus Clearance Among Mechanically Ventilated ICU Subjects. Respir Care. 2018 Dec;63(12):1471-1477. doi: 10.4187/respcare.06253. Epub 2018 Jul 17.
- Background: PubMed 30862688Lachal R, Louis B, Subtil F, Guerin C. Bench Assessment of the Effect of a Collapsible Tube on the Efficiency of a Mechanical Insufflation-Exsufflation Device. Respir Care. 2019 Jul;64(7):752-759. doi: 10.4187/respcare.06478. Epub 2019 Mar 12.
- Background: PubMed 24374746Morrow B, Zampoli M, van Aswegen H, Argent A. Mechanical insufflation-exsufflation for people with neuromuscular disorders. Cochrane Database Syst Rev. 2013 Dec 30;(12):CD010044. doi: 10.1002/14651858.CD010044.pub2.
- Background: PubMed 29616357Sanchez-Garcia M, Santos P, Rodriguez-Trigo G, Martinez-Sagasti F, Farina-Gonzalez T, Del Pino-Ramirez A, Cardenal-Sanchez C, Busto-Gonzalez B, Requesens-Solera M, Nieto-Cabrera M, Romero-Romero F, Nunez-Reiz A. Preliminary experience on the safety and tolerability of mechanical "insufflation-exsufflation" in subjects with artificial airway. Intensive Care Med Exp. 2018 Apr 3;6(1):8. doi: 10.1186/s40635-018-0173-6.
- Background: PubMed 28971036Bach JR. Noninvasive Respiratory Management of Patients With Neuromuscular Disease. Ann Rehabil Med. 2017 Aug;41(4):519-538. doi: 10.5535/arm.2017.41.4.519. Epub 2017 Aug 31.
- Background: PubMed 21801577Guerin C, Bourdin G, Leray V, Delannoy B, Bayle F, Germain M, Richard JC. Performance of the coughassist insufflation-exsufflation device in the presence of an endotracheal tube or tracheostomy tube: a bench study. Respir Care. 2011 Aug;56(8):1108-14. doi: 10.4187/respcare.01121.
- Background: PubMed 30018177Volpe MS, Naves JM, Ribeiro GG, Ruas G, Amato MBP. Airway Clearance With an Optimized Mechanical Insufflation-Exsufflation Maneuver. Respir Care. 2018 Oct;63(10):1214-1222. doi: 10.4187/respcare.05965. Epub 2018 Jul 17.
- Background: PubMed 25096928Bach JR, Saporito LR, Shah HR, Sinquee D. Decanulation of patients with severe respiratory muscle insufficiency: efficacy of mechanical insufflation-exsufflation. J Rehabil Med. 2014 Nov;46(10):1037-41. doi: 10.2340/16501977-1874.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Irene bello, Professor study chair
Vall d'Hebron Institute Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIE in people with Lung Transplant Failure, run by Vall d'Hebron Institute Research at 1 site in Spain.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jan 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene bello, Professor (620664172, irene.bello.rodriguez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in Oxygenation (time frame: Ten minutes after the MIE application and 60 minutes after MIE application or national protocol aplication). 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 NCT06202859, which also lists 20 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 12 Jan 2024.