Evaluation of performance of cuffed and uncuffed endotracheal tubes in a paediatric population: A randomised controlled trial.
Phase 4
Completed
- Conditions
- We hypothesize that there will be a higher rate of endotracheal tube leak in uncuffed compared with cuffed tubes, and that the rate of sore throat will be higher in the uncuffed group.We hypothesise that the rate of respiratory complications will be similar between the groups receiving either cuffed or uncuffed endotracheal tubes.We furthermore hypothesise that the loss in lung volume following a standardized recruitment maneouver will be greater in the children intubated with uncuffed ETTs as compared with cuffed ETTs.Anaesthesiology - Anaesthetics
- Registration Number
- ACTRN12612000045819
- Lead Sponsor
- Princess Margaret Hospital for Children
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 104
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method There will be a higher rate of endotracheal tube leak in uncuffed compared with cuffed tubes.<br>This will be assessed by calculating the difference between inspiratory and exspiratory tidal volumes.[Intraoperativley]
- Secondary Outcome Measures
Name Time Method The rate of sore throat will be higher in the uncuffed group.<br>This will be assessed postoperatively using a VAS scale 0-10.[Prior to dischcarge from ward to home]