Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163891
Status:
COMPLETED
Last Update Posted:
2006-10-04
First Post:
2005-09-12
Brief Title:
Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
A Prospective Randomised Two Month Trial Comparing Twho Chest Physiotherapy Protocols in Lung Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 lungsThere 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 futureongoing 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
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 lungsThere 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 futureongoing 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A10503 | None | None | None |