Comparison of anaesthetic face masks - a crossover trial to compare air entrainment using the standard BOC mask vs the intersurgical single use mask during preoxygenation
| ISRCTN | ISRCTN45706447 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45706447 |
| Protocol serial number | N0391148230 |
| Sponsor | Department of Health |
| Funders | West Dorset General Hospitals NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 21/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andy Ball
Scientific
Scientific
West Dorset General Hospitals NHS Trust
Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cross over randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Null hypothesis: that there will be no difference in the expired oxygen concentration. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
| Intervention | 20 to 30 subjects randomised into 2 groups. Each group will undergo 2 cycles of 3 minutes preoxygenation with each of the test masks, attached to the same anaesthetic circuit. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Comparison of area under the curve for expired oxygen concentration against time over 3 minutes. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | Between 20-30 subjects recruited from non-anaesthetic colleagues. |
| Key exclusion criteria | Respiratory disease, significant cardiac disease. |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
West Dorset General Hospitals NHS Trust
Dorchester
DT1 2JY
United Kingdom
DT1 2JY
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2007 | Yes | No |
