Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients
Condition: Lung Transplantation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Chest physiotherapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Respiratory Therapy; Postoperative Care; Treatment Outcome