None listed
Conditions
Brief summary
Neonatal mask ventilation (artificial breathing) is a technique that requires mastering, and previous simulation studies on manikin model suggest that mask leak is very common and significant in magnitude. Also airways obstruction occurs frequently when a resuscitator tries to minimise leak. A few studies in extremely preterm infants have suggested airways obstruction is common immediately after birth in infants requiring positive pressure ventilation. Studies in manikin models have described a simple 2-person four hand technique of mask ventilation that halves mask leak. Current UK neonatal guidelines (2010)suggest to consider using 2-person airway control on the basis of manikin studies. We propose to compare the current 1 person mask technique (Australian Resuscitation Council guideline, 2010) to 2 person mask technique. There are no studies available to inform which method is better. Aims : To measure respiratory function (lung function) parameters (mask leak, tidal volume, minute ventilation, end tidal CO2), and cerebral blood flow while using 1-person vs 2-person mask technique in delivery suite for extremely preterm infants.
Interventions
In 1-person method (which is the current standard technique) the resuscitator holds the mask in place with one hand and uses the other hand to provide positive pressure ventilation. In the 2-person method, one person holds the mask in place and the other person provides the positive pressure ventilation. Positive Pressure Ventilation(PPV) will be supplied if needed clinically as per International Liaison Commission on Resuscitation (ILCOR) guidelines using either a t-piece resuscitator (Neopuff
In 1-person method (which is the current standard technique) the resuscitator holds the mask in place with one hand and uses the other hand to provide positive pressure ventilation. In the 2-person method, one person holds the mask in place and the other person provides the positive pressure ventilation. Positive Pressure Ventilation(PPV) will be supplied if needed clinically as per International Liaison Commission on Resuscitation (ILCOR) guidelines using either a t-piece resuscitator (Neopuff (TM), Fisher & Paykel Healthcare, Auckland New Zealand) with starting settings of FiO2 30% Pressures of 25 cm H2O for peak inflation pressure and 5 cm H2O for positive end expiratory pressure. Self-inflating bag (Laerdal Medical, New York, USA) is also used routinely, as an alternative. Current routine care for premature infants born < 30wks gestation at Westmead includes the use of an intensive care newborn transport system that includes a neonatal ventilator, respiratory mechanics monitor and tissue saturation monitoring. A respiratory function monitor (Respironics NM3, Philips Healthcare, Best, The Netherlands) will be used in line with the mask to measure respiratory function parameters. This includes a sensitive end tidal CO2 monitor needed for clinical certainty for Endo Tracheal Tube (ETT) placement. A NIRS (Near Infra-Red Spectroscopy, Nonin Medical, Plymouth, Minnesota, USA) probe will be placed over the head to measure cerebral blood flow.
Sponsors
Neonatal Intensive Care Unit, Westmead Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Preterm infants at <30 weeks gestation requiring respiratory support in delivery suite
Exclusion criteria
Lethal congenital anomalies Upper airway anomalies Unavailability of the research team
Outcome results
None listed