Ease of placement of the laryngeal tube during manual-in-line neck stabilisation.
| ISRCTN | ISRCTN57834329 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57834329 |
| Protocol serial number | N0176140630 |
| Sponsor | Department of Health |
| Funders | Oxford Radcliffe Hospitals NHS Trust (UK), Not available |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 21/07/2009
- 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 Alexander Marfin
Scientific
Scientific
Department of Anaesthetics
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The laryngeal Tube (LT) is used in anaesthetics to secure patients' breathing and to administer oxygen and anaesthetic gases. LT consists of an airway tube with a small cuff attached at the tip (distal cuff) and a larger cuff at the middle part of the tube (proximal cuff). LT is inserted through the mouth. The proximal cuff provides a seal by forming a plug just above the voice box (larynx) and the distal cuff seals the gullet (oesophagus) inlet. There is a hole in the tube between the two cuffs to supply oxygen and anaesthetic gases through it. LT has a role in the airway management during anaesthesia and cardiopulmonary resuscitation. In patients with injury to the neck ("unstable necks"), airway management may be required while the head and neck are stabilised with the anaesthetist' assistant holding them in neutral position ("manual in-line sabilisation"). It is possible that this may make placement of the device more difficult. We wish to determine if the manual in-line stabilisation of the head and neck would alter the ease of insertion. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
| Intervention | Randomised controlled trial. Comparison of 2 different insertion positions |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Clinically assessed adequacy of the ventilation via LT inserted in two different positions. |
| Key secondary outcome measure(s) |
Ease and time of insertion of LT |
| Completion date | 30/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | 55 patients |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 30/04/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Anaesthetics
Oxford
OX3 9DU
United Kingdom
OX3 9DU
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 | 01/12/2004 | Yes | No |
