Cuffed versus uncuffed tracheal tubes in small children
| ISRCTN | ISRCTN92418744 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92418744 |
| Protocol serial number | N0436191394 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 02/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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 A Arana
Scientific
Scientific
Anaesthetics Department
D Floor
Jubilee Building
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Cuffed versus uncuffed tracheal tubes in small children |
| Study objectives | The main aim of this study is to compare side effects of using a breathing tube with a cuff which is inflated to form a seal around the tube with a tube without a cuff in children from birth to age 5 years undergoing surgery under general anaesthesia. The main measurement used will be the occurrence of noisy breathing (stridor) after the removal of the tube from the airway after surgery is complete. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Intubation |
| Intervention | Cuffed versus uncuffed tracheal tubes |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Primary aim of the present study is to compare post-extubation airway morbidity as measured as post-extubation stridor after using cuffed tracheal tubes with cuff pressure release valve versus using uncuffed tubes in children from birth up to 5 years. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 23/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 5 Years |
| Sex | All |
| Key inclusion criteria | 1. Children aged from birth (weighing >/= 3kg) to <5 years 2. Children requiring oro-tracheal or naso-tracheal intubation as a part of their anaesthetic care and planned ventilatory support during the surgical, interventional or diagnostic procedure. 3. Tracheal intubation performed using direct laryngoscopy 4. Extubation after the procedure in the operating theatre 5. Procedure performed in the supine position 6. Patients for elective and emergency surgery and/or interventions if there is no risk of regurgitation or pulmonary aspiration ASA 1 and 2 patients (ie normal or mild systemic disease) 7. Written parental consent |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 23/01/2007 |
| Date of final enrolment | 23/01/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
LS1 3EX
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
