Respiratory Physiotherapy as a Tool to Increase the Number of Solid Organ Donors

NCT06202859 | Unknown

• 1 other identifier: MIE-don study
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

respiratory physiotherapy; lung donor; improve lung donor

Outcome Measures

Primary Outcomes (1)

• The changes in Oxygenation

  The changes of oxygenation comparing MIE to national protocol

  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

  During the intervention and 60 minutes after it.

• Number of potential lung donors

  during the recruitment time

• Number of lung donors

  during the recruitment time

Study Arms (2)

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.

Device: MIE

Control group

ACTIVE COMPARATOR

Maintained following national guidelines.

Device: MIE

Interventions

MIE DEVICE

Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips.

Control group; MIE group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Organ donor older than 18yo

You may not qualify if:

• Absolute contraindications for MIE's use
• Absolute contraindications for organ donation

Sponsors & Collaborators

• Vall d'Hebron Institute Research: lead
• Hospital Vall d'Hebron: collaborator
• Germans Trias i Pujol Hospital: collaborator
• Hospital Universitario Marqués de Valdecilla: collaborator

Study Sites (1)

Irene bello

Barcelona, 08024, Spain

RECRUITING

Related Publications (20)

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  PMID: 23722822 BACKGROUND

• Battaglini 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.

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• Thomas 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.

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• Fernandez-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.

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• Ferreira 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.

  PMID: 30018175 BACKGROUND

• Lachal 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.

  PMID: 30862688 BACKGROUND

• Morrow 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.

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• Sanchez-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.

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• Guerin 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.

  PMID: 21801577 BACKGROUND

• Volpe 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.

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• Bach 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.

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• Toussaint 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.

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• Goncalves 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.

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• Terzi N, Prigent H, Lofaso F. Mechanical Insufflation-Exsufflation to Improve Secretion Clearance During Invasive Ventilation. Respir Care. 2018 Dec;63(12):1577-1578. doi: 10.4187/respcare.06700. No abstract available.

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• Minambres E, Ballesteros MA, Rodrigo E, Garcia-Miguelez A, Llorca J, Ruiz JC, Arias M. Aggressive lung donor management increases graft procurement without increasing renal graft loss after transplantation. Clin Transplant. 2013 Jan-Feb;27(1):52-9. doi: 10.1111/j.1399-0012.2012.01690.x. Epub 2012 Aug 16.

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  PMID: 33246712 BACKGROUND

Study Officials

• Irene bello, Professor

  Vall d'Hebron Institute of Research

  STUDY CHAIR

Central Study Contacts

Irene bello, Professor

CONTACT

620664172; irene.bello.rodriguez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: January 12, 2024
• Study Start: November 1, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: IPD will become available since the publications during 3 years
• Access Criteria: IPD will be available for researchers involved in organ donation, respiratory physiotherapy or lung transplantation who asked by email to main researcher.

Locations

ES (1)