Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
02/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A Arana

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436191394

Study information

Scientific title

Cuffed versus uncuffed tracheal tubes in small children

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Intubation

Intervention

Cuffed versus uncuffed tracheal tubes

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

23/01/2007

Overall trial end date

23/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

23/01/2007

Recruitment end date

23/01/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes