Use of 3-helium MRI scanning to determine efficacy of chest physiotherapy in cystic fibrosis

ISRCTN	ISRCTN16158695
DOI	https://doi.org/10.1186/ISRCTN16158695
Secondary identifying numbers	N0220184922

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 17/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof C J Taylor
Scientific

Academic Unit of Child Health
Floor C, Stephenson Wing
Sheffield Children's NHS Foundation Trust
Western Bank
Sheffield
S10 2TH
United Kingdom

Phone	+44 (0)114 271 7304
Email	c.j.taylor1@sheffield.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Use of 3-helium MRI scanning to determine efficacy of chest physiotherapy in cystic fibrosis
Study objectives	The aim of this study is to confirm the efficacy of chest physiotherapy in promoting airway mucus clearance in cystic fibrosis (CF).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cystic fibrosis
Intervention	We have previously shown that 3-helium MRI scanning provides a reliable and reproducible means of imaging the chest of CF. The technique is well tolerated in children as young as 5 years and can show changes in both lung structure and function without exposing the subjects to the risks of radiation. We proposed to use 3-helium MRI scanning to demonstrate the efficacy of airway clearance techniques and to compare different types of chest physiotherapy. Children with CF attending the Regional CF Centre at Sheffield Children's Hospital will be recruited into an open study. 3-helium MRI scanning will be performed before and after a session of chest physiotherapy administered by a trained physiotherapist. Subjects will be randomised to receive one of three different methods of airway clearance, all in routine use in this clinic. Changes in the lung fields and dynamic changes in lung function will be assessed from the MR images using an established scoring system. Assignments will be performed by an independent observer blinded to the method of chest physiotherapy employed. Changes in MR score will be compared with conventional methods of lung function testing (spirometry) and the degree of change correlated with the patients' general condition (Shwachmann and Chrispin Norman scores) derived from their annual review data.
Intervention type	Other
Primary outcome measure	Change in dynamic lung function as demonstrated by 3-helium MR scanning, post chest physiotherapy
Secondary outcome measures	Further demonstration of the use of 3-helium scanning to relate structural to functional change in the lung
Overall study start date	17/08/2006
Completion date	31/05/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	5 Years
Sex	Both
Target number of participants	60
Key inclusion criteria	1. Patients with CF 2. Aged <5 years 3. Able to perform spirometry
Key exclusion criteria	Patients undergoing a significant respiratory exacerbation sufficient to prevent lung function testing.
Date of first enrolment	17/08/2006
Date of final enrolment	31/05/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Academic Unit of Child Health

Sheffield
S10 2TH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Sheffield Children's NHS Foundation Trust (UK)

No information available

NHS R&D Support Funding (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

17/05/2017: No publications found in PubMed, verifying study status with principal investigator