| Methods |
Subjects were randomly assigned (coin toss) to experimental and control groups. A stabilization method was implemented in the experimental group and the more traditional method of stabilizing an endotracheal tube was performed on the control group. |
| Participants |
Thirty preterm infants at least 27 weeks gestation who required mechanical ventilation. Exclusion criteria used included infants medicated with pancuronium bromide (or similar paralysing drugs), infants less than 27 weeks gestation and infants intubated for less than 6 days |
| Interventions |
The intervention was the stabilization method employed for subjects in the experimental group. The stabilization device consisted of a slip lock, a cylinder and a holder. The endotracheal tube was held in position within the cylinder by the slip lock which secured it. The holder had a sticky surface that adhered to the baby's face |
| Outcomes |
The rate of accidental extubation, the number of re‐stabilizations required to maintain endotracheal tube stability and the amount of endotracheal tube slippage |
| Notes |
The groups were similar at the start of the trial |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
The random sequence was generated by the toss of a coin |
| Allocation concealment (selection bias) |
Unclear risk |
It was not stated whether allocation was concealed |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Treatment could not be blinded due to the nature of the study |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Outcome assessments could not be blinded due to the nature of the study. Data were collected and recorded by the subject's bedside nurse. This included the number of re‐stabilizations required to maintain endotracheal tube stability, the reason each re‐stabilization was necessary, the approximate time required to reapply the method of stabilization, the number of extubations exhibited and the cause of extubation |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
It was stated in the methods that an additional 9 subjects "were enrolled in the study but were subsequently dropped when each extubated prior to the completion of the 6 day study period. One female subject was dropped from the study as a result of mortality prior to the completion of the 6 day study period" |
| Selective reporting (reporting bias) |
Unclear risk |
See above "incomplete outcome data entry" |
| Other bias |
Unclear risk |
It was not stated whether the groups were treated equally apart from the intervention |
