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 |
| Protocol serial number | N0226167746 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | South Manchester University Hospitals NHS Trust (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Increasing oxygen flow rate is beneficial to breathless patients |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 20 |
| 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
- United Kingdom
- England
Study participating centre
The Manchester Adult Cystic Fibrosis Centre
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
