A pilot study to determine whether increasing oxygen flow rate or oxygen percentage through a fixed performance mask relieves breathlessness in patients with cystic fibrosis
| ISRCTN | ISRCTN60112193 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60112193 |
| Secondary identifying numbers | N0226167746 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 06/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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
Dr Andrew M Jones
Scientific
Scientific
The Manchester Adult Cystic Fibrosis Centre
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 0161 291 2154 |
|---|---|
| andrew.jones@uhsm.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To compare whether changing oxygen flow or oxygen percentage through a fixed performance mask relieves breathlessness in patients with cystic fibrosis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Cystic fibrosis |
| Intervention | Cohort of stable CF Patients. Patients will perform a maximal bicycle ergometric exercise test on room air (under supervision of a specialist CF physiotherapist and doctor) to determine work rate & associated peak respiratory flow rate. VAS is assessed each minute to specifically determine degree of breathlessness. Following the exercise test VAS is assessed in recovery. Patients are rested and randomly assigned one of three exercise tests over two days. These exercise tests use either an increasing oxygen concentration mask (flow rate remains the same). Relief of breathlessness will be determined by VAS scoring. Added Seyember 2008: trial stopped due to lack of resources. |
| Intervention type | Other |
| Primary outcome measure | Increasing oxygen flow rate is beneficial to breathless patients |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2005 |
| Completion date | 30/12/2007 |
| Reason abandoned (if study stopped) | Lack of resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 20 patients to be recruited from the Manchester Adult Cystic Fibrosis Unit. |
| Key inclusion criteria | 1. Cystic fibrosis patients aged over 16 2. Clinically stable 3. Able to give informed consent |
| Key exclusion criteria | Patients having respiratory exacerbation |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 30/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Manchester Adult Cystic Fibrosis Centre
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
South Manchester University Hospitals NHS Trust (UK), NHS R&D Support Funding
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 |
