Evaluation of performance of cuffed and uncuffed endotracheal tubes in a paediatric population: A randomised controlled trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000045819

Acronym

Cuffed versus Uncuffed ETT

Enrollment

104

Registered

2012-01-10

Start date

2011-12-22

Completion date

2014-01-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Having an operation is very safe for most patients and we wish to do research to improve patient care. To ensure the safe delivery of oxygen and anaesthesia gases to the child, the anaesthetist will insert a tube into the child’s mouth. Then the child’s lungs can be inflated and deflated by these gases. There are two tubes which can be used for this purpose. Both look very similar, except one has an inflatable balloon on the end. Both devices do the same thing and have been independently shown to be safe for use in children. However, a direct comparison between the two tubes is lacking in the paediatric population on how easily the lungs can be inflated. Therefore, the first aim of this study is to show if there are differences in inflating the child’s lungs. The second aim is to show there are no differences in the potential injury to the child’s throat from either tube type.

Interventions

Comparing the use of Cuffed endotracheal tubes (ETT) to Uncuffed endotracheal tubes in the paediatric population. The tubes will be used during elective surgery requiring invasive airway management. The duration of use will depend on the duration of the procedure in general between 30 and 120 min.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 16 Years

Healthy volunteers

Inclusion criteria

104 Children, aged 0 to 16 years, male or female, > 5 kg, undergoing elective surgery not showing any contraindications for the use of a cuffed or uncuffed ETT device (as assessed by an anaesthetist independent of the study team).

Exclusion criteria

Airway malformations (including Tonsillectomy & Adenotonsillectomy) Contraindication for use of a cuffed or uncuffed ETT airway device as assessed by an anaesthetist independent of the study team Likely postoperative ventilation on ICU. Throat packs required

Outcome results