Cuffed versus uncuffed tracheal tubes in small children

ISRCTN	ISRCTN92418744
DOI	https://doi.org/10.1186/ISRCTN92418744
Secondary identifying numbers	N0436191394

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

Dr A Arana
Scientific

Anaesthetics Department
D Floor
Jubilee Building
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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.
Secondary outcome measures	Not provided at time of registration
Overall study start date	23/01/2007
Completion date	23/01/2008

Participant type(s)	Patient
Age group	Child
Upper age limit	5 Years
Sex	Both
Target number of participants	Not provided at time of registration
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

Leeds General Infirmary

Leeds
LS1 3EX
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Leeds Teaching Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

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