None listed
Conditions
Brief summary
A randomised controlled trial of a Respiratory Function Monitor during positive pressure ventilation (intervention) compared to positive pressure ventilation (control) (in line with the Australian Resuscitation Council guidelines) during resuscitation of infants. The duration of the trial is 12 months; we anticipate completing recruitment in October 2009. Does the use of a respiratory Function Monitor during positive pressure ventilation reduce face mask leak and improve the target tidal volume in the first ten minutes of life? During the stressful event of neonatal resuscitation neonatologists do not consider the tidal volume (VT) they deliver, or if there is a leak between the face and the mask. We hypothesis that a respiratory function monitor will reduce the face mask leak and support the clinician to deliver the target tidal volume during positive pressure ventilation. Ventilation using a face mask is the main technique used to support infants who breathe inadequately immediately after birth. However, a major problem is the often large and variable gas leak between the mask and face. Face mask leak occurs frequently, even for experienced operators and seriously affects the delivered tidal volume. The tidal volume changes as the leak changes, even though the same inflating pressure is used. In practice this means that for the same inflating pressure the tidal volume may be low, appropriate or excessive depending on the leak. Furthermore immediately after birth it is not possible to deliver an appropriate tidal volume using ventilation with a set pressure because the compliance of the lung varies from infant to infant and during the course of lung aeration. It is therefore necessary to measure and adjust the tidal volumes delivered during positive pressure ventilation in the minutes after birth, especially in very preterm infants. We hypothesis that a respiratory function monitor will reduce the face mask leak and support the clinician to deliver the target tidal volume during positive pressure ventilation.
Interventions
A randomised controlled trial of a Respiratory Function Monitor during positive pressure ventilation during resuscitation of infants. A flowsensor will be placed between the mask and the Neopuff T-piece-device. This flowsensor measures the airflow and calculates the tidal volume. Each infant requiring positive pressure ventilation at birth will be recorded with the flowsensor in place, the duration of this recording will last during the initial stabilisation in the delivery room.
The duration of
A randomised controlled trial of a Respiratory Function Monitor during positive pressure ventilation during resuscitation of infants. A flowsensor will be placed between the mask and the Neopuff T-piece-device. This flowsensor measures the airflow and calculates the tidal volume. Each infant requiring positive pressure ventilation at birth will be recorded with the flowsensor in place, the duration of this recording will last during the initial stabilisation in the delivery room. The duration of the trial is 12 months; we anticipate completing recruitment in October 2009.
Sponsors
Professor Colin J Morley
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Infants born in the Royal Women's Hospital who need positive pressure ventilation for resuscitation in the delivery room
Exclusion criteria
Infants will be excluded from final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: Congenital Diaphragmatic Hernia. Infants will also be excluded if their parents refuse to give consent to this study.
Outcome results
None listed