Effects of carbon monoxide on nasal mucociliary clearance
| ISRCTN | ISRCTN54813440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54813440 |
| Secondary identifying numbers | N0236169531 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 22/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
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
Mr Stephen Lo
Scientific
Scientific
Department of Otolaryngology
St George's Hospital Medical School
London
SW17 0QT
United Kingdom
| Phone | +44 (0)20 8725 2050 |
|---|
Study information
| Study design | Prospective single-blinded controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | To determine the effects of low concentrations of carbon monoxide gas on the motility of human nasal cilia cells. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ear, Nose and Throat |
| Intervention | A steady flow of normal air (100 ml/min) is fed into one nostril; the other nostril is left unblocked so air can escape. Simultaneously, the subject breathes via the mouth into an oxygen mouthpiece so that the soft palate closes the mouth from the nasal cavity, and gas flows from one nostril to the other without being inspired into the lungs. This lasts for 10 minutes. The saccharine test is then used to measure the nasal mucociliary clearance time. A saccharine granule is placed in the nose at the same site in all subjects. The time required for the subject to taste the sweetness is measured. Oral only breathing is maintained during the saccharine test. The test is repeated with a 100 cc/min flow of low concentration CO gas (30 ppm) fed into the nostril. The subject is blinded and does not know which gas is fed into the nostril. The nostril into which the gas is fed into is randomised. The background ambient CO level is measured using a commercially available CO detector. |
| Intervention type | Other |
| Primary outcome measure | The mucociliary clearance time, measured as the time to taste the saccharin |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 21/08/2005 |
| Completion date | 21/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Added 21/07/2008: 26 |
| Key inclusion criteria | Healthy adult volunteers between 18 and 40 years old. Volunteers will be recruited from amongst medical and nursing staff and students at St Georges Hospital, London. They will be personally approached by the principle investigator. |
| Key exclusion criteria | 1. Smokers 2. Subjects with a history of chronic respiratory or nasal disease 3. Symptomatic upper respiratory tract infection during the previous 4 weeks 4. Subjects who have taken systemic or topical steroids or anti-histamine therapy during the previous 4 weeks 5. Presence of significant mechanical intra-nasal deformity such as a septal deviation or bony spur 6. Children under 16 years old 7. Vulnerable groups including those with learning difficulty, mental illness and dementia 8. Pregnancy 9. Other conditions that increase risk are hyperthyroidism, obesity, bronchitis, asthma, pre-existing heart disease and alcoholism |
| Date of first enrolment | 21/08/2005 |
| Date of final enrolment | 21/08/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Otolaryngology
London
SW17 0QT
United Kingdom
SW17 0QT
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
St George's Healthcare NHS 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 |
