Lung Transplantation Clinical Trial
Official title:
A Prospective Randomised Two Month Trial Comparing Twho Chest Physiotherapy Protocols in Lung Transplant Recipients
Chest infection is a common complication following lung transplant (LTx). Chest
physiotherapy is widely accepted as an integral part of the management of chest infections,
however there is no evidence available regarding the effectiveness of chest physiotherapy
regimes for LTx recipients.
There is no consensus regarding whether LTx recipients should be instructed to perform
regular daily chest physiotherapy routines regardless of the presence of lung secretions (ie
prophylatically) because of the changes in mucus clearance bought about by lung transplant,
or only when they have a chest infection. Some clinicians believe that a prophylactic
regimen may be beneficial.
This research will compare two chest physiotherapy treatment regimens - our current practice
of chest physiotherapy during chest infections only (Treatment A) with an independently
performed daily chest physiotherapy regimen regardless of the presence of a chest infection
(Treatment B). From this research, we aim to develop evidence-based treatment guidelines.
Very little is known about the effectiveness of chest physiotherapy protocols in lung
transplant recipients. Clinical practice is based upon the experiences of individual
clinicians and generalisations from other patient populations.
There is anecdotal evidence (from discussion with physiotherapists at the European Cystic
Fibrosis Conference, 2001) that some lung transplant centres are advising their patients to
undertake daily (prophylactic) chest physiotherapy as part of their usual routine. They
believe that this may compensate for the reduced stimulus to cough caused by the lack of
vagal nerve supply to the transplanted lung/s.There is no evidence that this time consuming
intervention is of any benefit to the patient in the short or longer term.
Some patients have bronchial anastomotic complications and dynamic airway collapse that may
further impair secretion removal. The mechanical effects of Positive Expiratory Pressure
(PEP) mask Physiotherapy, particularly its ability to splint open airways, provides a
theoretical basis for why this technique may be beneficial to lung transplant recipients. We
have also noted a clinical benefit in a small number of patients who have been treated with
PEP.
This study aims to evaluate two chest physiotherapy protocols using a variety of outcome
measures and act as a starting point for future/ongoing research in this important clinical
area.
This study is a prospective randomised two month trail comparing two chest physiotherapy
protocols in lung transplant recipients.
The protocols are:
Treatment A – Positive expiratory pressure (PEP) mask physiotherapy in upright sitting
carried out only during chest infections
Treatment B – Positive expiratory pressure (PEP) mask physiotherapy in upright sitting
performed twice daily as a prophylactic routine
The null hypotheses are:
1. Comparing Treatment A & B, there will be no difference in:
- Lung function
- Chest X ray (Brasfield scores)
- Airway status (Bronchoscopy scores)
- Days in hospital due to chest infection
- Days on antibiotics
- Exercise capacity (6 minute walk test)
- Quality of life
2. There will be no difference in patient adherence to the alternative protocols.
3. There will be no difference in patient satisfaction with the alternative protocols.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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