None listed
Conditions
Brief summary
Preterm infants often need breathing support delivered through a mask placed on their faces (mask ventilation). Studies have shown that mask ventilation can be complicated by leak around the mask causing it to be less effective. Australian Resuscitation Council guidelines state ‘the appropriate size of face mask must seal around the mouth and nose but not cover the eyes or overlap the chin.’ A standard 50mm diameter soft round silicon mask (Laerdal 0/0) has been the mask of choice historically used at the Royal Women’s Hospital. However a recent study has shown that a smaller mask may comply better with guidelines. The aim of this study is to compare leak using a 50mm diameter mask compared to either 35mm (infants 26 weeks or less corrected gestational age) or 42mm ( 27 weeks or greater corrected gestational age) diameter masks (Fisher & Paykel neonatal resuscitation masks extra small or small). The study is a randomised controlled trial. The population is preterm infants less than 33 weeks gestation who require intubation while inpatient in the neonatal intensive care unit. The term intubation refers to the insertion of a breathing or endotracheal tube into the infant’s airway, so that they can be supported by a ventilator. Before the insertion of the tube, the infant receives premedication that sedates and gives pain relief but will cause the infant to stop breathing necessitating a predictable period of mask ventilation. The intervention group will receive either the 35 or 42mm mask to deliver mask ventilation, the control group the 50mm mask. The primary outcome is the difference in leak measured between the mask and the infant’s face between control and intervention groups.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Inpatient preterm infants less than 33 weeks post menstrual age requiring mask intermittent positive pressure ventilation before an elective intubation attempt with premedication.
Exclusion criteria
1. Infants in the delivery room or operating theatre who require endotracheal intubation will not be eligible for entry to this study. 2. Infants with a congenital anomaly of their face which may affect the ability of a mask to create a seal will be excluded.