Randomized crossover comparison of mask leak between facemask and nasal mask ventilation; a pilot study.

The most frequent used interface during resuscitation with the self-inflating
bag or a mechanical T-piece device, is the facemask. Studies have shown that
inadequate sealing between face and mask often leads to inappropriate and
inconsistent peak inspiratory pressures (PIP) and positive end expiratory
pressure (PEEP), which may be harmful. Effective resuscitation at birth may
improve clinical outcome in preterm infants.
Segedin et al. showed that manual ventilation can be better performed via the
nasal route. It has been shown that delivery of positive pressure ventilation
though the nasal route via nasal prongs is favourable in terms of outcome
(chest compressions and intubation) compared to delivery through a face mask.
There however is limited evidence that other device who use the nasal route,
deliver efficient PIP and PEEP during resuscitation by decreasing the amount of
leak. Examples of these devices are the nasal canula and the nasal mask. The
applicability of these devices will alleviate the dependence on sufficient
sealing by a facemask, providing that both the mouth and the other nostril are
closed during resuscitation.
The nasal mask is often used in the unit as interface to deliver non-invasive
respiratory support (continuous positive airway pressure (CPAP) or nasal
intermittent mandatory ventilation). In other units it is used to deliver
respiratory support in preterm infants at birth. However, so far the
effectiveness of the nasal mask has not been tested and compared with the
facial mask. To create rationale for a larger clinical trial we wish to perform
a small pilot study comparing the effectiveness of a nasal mask with the
standard facemask in preterm infants needing positive pressure ventilation.

To compare the occurrence of significant mask leak when using a nasal mask
versus a facemask in preterm infants needing positive pressure ventilation.

This is a non-blinded randomized controlled crossover trial which will be
performed in the neonatal unit in the Leiden University Medical Center, Leiden,
the Netherlands.

It is standard as part of the intubation procedure that infants are mask
ventilated right after sedation and prior to intubation. Two T-piece
resuscitation devices will be prepared, one with the allocated device and one
with face mask as interface. In this way a fast switch to the other interface
can be performed and takes only a few seconds. The allocated interface will be
used for one minute after which the resuscitator switches to the other device.
In any case, if the infant*s condition deteriorates, the resuscitator will
immediately switch to standard procedure and use the mask as interface.