None listed
Conditions
Brief summary
Newborn intensive care provides life-saving mechanical ventilation when the lungs of a very ill baby deteriorate with illness and need assistance to provide blood oxygen and removal of blood carbon dioxide. This involves the routine placement of a soft plastic tube called an endotracheal tube into the main breathing passageway called the trachea. This tube is placed via the nose or the mouth and mediations are used to relax the baby to ensure the procedure occurs with minimal disturbance. With these medications, the medical staff will provide breaths with a mask placed over the mouth and nose. There are two recognized ways of holding the mask. In both methods some leak of the breath provided occurs around the mask and occasionally a degree of obstruction occurs. This study seeks to determine which method is better. These methods are; where one person holds the mask in place with one hand and provides breaths with the other hand compared to the other method where one person holds the mask and another person provides the breaths. The purpose is to investigate whether by using a two-person method for mask ventilation; we are able to reduce the leak and airway obstruction so that the ventilation is more effective.
Interventions
Mask ventilation with a 2 person method whereby one person holds the mask over the neonate's face with both hands and the second person provides the positive pressure breaths.
Duration of mask ventilation will be 5-10 minutes. It will be given once only. Endotracheal intubation will be performed immediately after mask ventilation has stabilised baby's oxygenation level. Follow up includes data collection from the monitors immediately after the intervention has concluded. There is no longer term
Mask ventilation with a 2 person method whereby one person holds the mask over the neonate's face with both hands and the second person provides the positive pressure breaths. Duration of mask ventilation will be 5-10 minutes. It will be given once only. Endotracheal intubation will be performed immediately after mask ventilation has stabilised baby's oxygenation level. Follow up includes data collection from the monitors immediately after the intervention has concluded. There is no longer term follow up.
Sponsors
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 3 Months
Healthy volunteers
No
Inclusion criteria
1. Gestation less than 30 weeks 2. Undergoing non-emergent endotracheal intubation in the neonatal intensive care unit for any one of the following indications: a. Recurrent episodes of apnoea b. Rapidly rising oxygen requirement or oxygen requirement more than 40% on nasal continuous positive airway pressure of 8 cm H2O c. Respiratory acidosis with pH less than 7.25 and PaCO2 more than 55 mm Hg d. Increasing work of breathing such that in the opinion of the treating neonatologist, the neonate in likely to exhaust himself/herself e. Large airway leak in an already intubated neonate where ongoing ventilation is required. A larger endotracheal tube will be inserted in this situation.
Exclusion criteria
1. Neonates with lethal congenital anomalies 2. Neonates with upper airway anomalies 3. Intubation required urgently (cardiorespiratory instability) 4. Unavailability of the research team
Outcome results
None listed