Objective To study effectiveness and safety of cuffed versus uncuffed endotracheal tubes (ETTs) in small infants in the intensive care unit (ICU).
Design Pilot RCT.
Setting Neonatal and paediatric ICUs of children’s hospital in Western Australia.
Participants Seventy-six infants ≥35 weeks gestation and infants <3 months of age, ≥3 kg.
Interventions Patients randomly assigned to Microcuff cuffed or Portex uncuffed ETT.
Main outcomes measures Primary outcome was achievement of optimal ETT leak in target range (10%–20%). Secondary outcomes included: reintubations, ventilatory parameters, ventilatory complications, postextubation complications and long-term follow-up.
Results Success rate (achievement of mean leak in the range 10%–20%) was 13/42 (30.9%) in the cuffed ETT group and 6/34 (17.6%) in uncuffed ETT group (OR=2.09; 95% CI (0.71 to 6.08); p=0.28). Mean percentage time within target leak range in cuffed ETT group 28% (IQR: 9–42) versus 15% (IQR: 0–28) in uncuffed ETT group (p=0.01). There were less reintubations to optimise size in cuffed ETT group 0/40 versus 10/36 (p<0.001). No differences were found in gaseous exchange, ventilator parameters or postextubation complications. There were fewer episodes of atelectasis in cuffed ETT group 0/42 versus 4/34 (p=0.03). No patient had been diagnosed with subglottic stenosis at long-term follow-up.
Conclusions There was no difference in the primary outcome, though percentage time spent in optimal leak range was significantly higher in cuffed ETT group. Cuffed ETTs reduced reintubations to optimise ETT size and episodes of atelectasis. Cuffed ETTs may be a feasible alternative to uncuffed ETTs in this group of patients.
Trial registration number ACTRN12615000081516.
Data availability statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Contributors RET was the principal investigator for this project, designed the study, designed the data collection instruments, collected and entered data, drafted the initial manuscript, and reviewed and revised the manuscript. SCR conceptualised and designed the study, and reviewed and revised the manuscript. SE, BH, ML, CM and SV designed the study and critically reviewed the manuscript for important intellectual content. SA coordinated the later part of the trial, collected data and reviewed the manuscript for important intellectual content. MKB performed the statistical analyses and critically reviewed the manuscript for important intellectual content. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Funding RET received a fully funded Telethon Fellowship to carry out this project.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.