Cuffed Versus Uncuffed Endotracheal Tubes for Ventilation of Neonates and Infants in the Neonatal and Paediatric Intensive Care Unit: A Pilot RCT

The purpose of this pilot study is to show the efficacy of using cuffed endotracheal tubes (ETT) for longer term ventilation in neonates >3kg and infants <3 months in the neonatal and paediatric intensive care setting. Cuffed ETTs potentially offer the advantage of a less or more manageable air leak and therefore improved ventilation. This is extremely relevant in theatre and in the intensive care unit (ICU) where inflammation, fluid shifts and changes in lung compliance result in dynamic changes. There has been much debate in recent years over the use of cuffed versus uncuffed ETTs for the ventilation of neonates, infants and children. Traditionally, uncuffed ETTs have been used due to historical, unsubstantiated concerns over the safety of using cuffed ETTs in small children. However, over the last few years with the advent of the newer high-volume low-pressure cuffed tubes (HVLP), there has been an increase in the use of cuffed tubes in children from birth (>3kg) particularly during anaesthesia for surgical procedures. There has also been an increase in use for longer term ventilation in the PICU. Our hospital is now using cuffed ETTs in small children from birth for anaesthesia in theatre and they are also commonly used in PICU. They are sometimes being used in term neonates in the NICU when they come back from theatre with one in place. Most of the data available in the literature concerns short term use of cuffed ETTs in the anaesthetic setting, but data supporting the use of cuffed or uncuffed tubes for longer term ventilation in neonates and infants is poorly studied. It is an important question as complications with regard to inadequate ventilation contribute to prolonged hospital stay and inappropriate tube selection and multiple tube changes contribute to airway trauma potentially requiring airway reconstruction inferring a high cost to the patient and health care system. This is a pilot RCT to begin the process of bringing some proper scientific rigor to the subject. It will take place at PMH in 6B (NICU) and PICU with the involvement of anaesthetics when the tube is placed in theatre. It will include neonates >3kg and infants up to 3 months of age. Patients will be randomised to receive a cuffed or uncuffed ETT and then data will be collected to look at the primary outcome of tube leak. The secondary objective is to show comparable or improved safety and improvement in the ability to ventilate with cuffed ETTs when compared with uncuffed ETTs. With this initial study, we hope to show that safety and efficacy is at least on a par with the traditional uncuffed ETTs and maybe a trend towards improved ventilation. With these initial results, we will go on to set up a larger multi-centre RCT to look at the outcomes in more detail.