None listed
Conditions
Brief summary
Around 3-6% of newborn infants require positive pressure ventilation (PPV) in the delivery room (DR). However, delivering effective mask ventilation can be challenging, because of large leak around the mask. The presence of a large leak may lead to ineffective ventilation and an unsuccessful resuscitation. A new face mask called Resusi-sure (LSR Health care, NSW, Australia) uses suction to create a seal between the mask and the infant’s face. Primary objective is to test (in a randomised trial) the hypothesis that there will be less leak during intermittent positive pressure ventilation of term and near term infants (newly born infants greater than or equal to 34 weeks) in the delivery room if performed with the suction mask compared with the conventional mask.
Interventions
Mask ventilation will be performed using the suction mask (60 mm). Either CPAP or intermittent positive pressure ventilation will be performed by a neonatal resident, fellow or consultant.
The suction mask called Resusi-sure (LSR Health care, NSW, Australia) uses suction to create a seal between the mask and the infant’s face. This mask has a vacuum chamber between the inner and the outer rim and has a side port to connect to standard tubing used by suction apparatus on the resuscitation troll
Mask ventilation will be performed using the suction mask (60 mm). Either CPAP or intermittent positive pressure ventilation will be performed by a neonatal resident, fellow or consultant. The suction mask called Resusi-sure (LSR Health care, NSW, Australia) uses suction to create a seal between the mask and the infant’s face. This mask has a vacuum chamber between the inner and the outer rim and has a side port to connect to standard tubing used by suction apparatus on the resuscitation trolley. The mask has Australian Therapeutic Goods Administration approval (June 2015). A negative pressure of -75 mmHg will be used to form a seal and used for the duration of mask use. All other devices are set up as per standard hospital guideline for a resuscitation of a term baby. The initial setups are flow 10 l/min, Pip 30, Peep 5, no humidity, FiO2 0.21 and are escalated according to the physicians discretion and the infants response to rescucitation.
Sponsors
The Royal Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
term and late preterm appropriately grown infants with gestational age (GA) at birth greater than or equal to 34 weeks AND who require either CPAP (continuous positive airway pressure) or IPPV (intermittent positive pressure ventilation) in the delivery room/ operating theatre within the first 10 minutes after birth.
Exclusion criteria
* congenital anomaly of the face, which may affect the ability of a mask to create a seal. * inability of research team to attend * not eligible for Medicare
Outcome results
None listed