Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2014
INTERVENTION: If mask ventilation is required prior to elective intubation, it will be performed using either the 35 or 42mm silicone Fisher & Paykel neonatal resuscitation masks. Infants less than 26 weeks post menstrual age will be allocated the 35mm mask and infants 27‐32 weeks post menstrual age will be allocated the 42mm mask. The positive pressure ventilation will be performed by a Paediatric doctor. CONDITION: Prematurity PRIMARY OUTCOME: Difference in leak measured between the mask and the infant’s face between the control and intervention groups. ; ; A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) will be used to measure inflating pressures and gas flow via a flow sensor between the mask and the Neopuff. Tidal volumes, and expiratory leak will be measured by the flow sensor. Expiratory leak will be calculated from the volume of gas that does not return back through the flow sensor on expiration, expressed as a percentage of the inspired volume. ; ; Spectra software (Grove Medical, London, UK) will record the leak, tidal volumes and delivered pressures SECONDARY OUTCOME: Difference in tidal volumes. ; ; A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) will be used to measure inflating pressures and gas flow via a flow sensor between the mask and the Neopuff. Tidal volumes will be measured by the flow sensor. ; ; Spectra software (Grove Medical, London, UK) will record the leak, tidal volumes and delivered pressures. Duration of positive pressure ventilation Number of attempts of repositioning of the mask Percentage of obstructed breaths. ; ; A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) will be used to measure inflating pressures and gas flow via a flow sensor between the mask and the Neopuff. Tidal volumes will be measured by the flow sensor. ; ; ; Spectra software (Grove Medical, London, UK) will record the leak, tidal volumes and delivered pressures. The percentage of breaths that are obstructed (where there is no or little tidal volume recorded) will be calculated from these recordings. Positive inspiratory pressure administered. ; ; A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) will be used to measure inflating pressures and gas flow via a flow sensor between the mask and the Neopuff. ; ; Spectra software (Grove Medical, London, UK) will record the delivered pressures. The highest inspired oxygen (FiO2) administered ; ; A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) with an oxygen analyser will be used to measure the inspired oxygen concentration. ; ; Spectra software (Grove Medical, London, UK) will record the inspired oxygen concentration. The infant’s lowest heart rate during mask ventilation ; ; A pulse oximeter feeding data directly to spectra software (Grove Medical, London, UK) will be attached to the infant throughout the study and will be used to determine the infant’s changes in heart rate. The infant’s lowest oxygen saturation during mask ventilation. ; ; A pulse oximeter feeding data directly to spectra software (Grove Medical, London, UK) will be attached to the infant throughout the study and will be used to determine the infant’s changes in oxygen saturation. INCLUSION CRITERIA: Inpatient preterm infants less than 33 weeks post menstrual age requiring mask intermittent positive pressure ventilation before an elective intubation attempt with premedication.
Epistemonikos ID: f112f5892077905d3f7c972118dcc77cf5ff2d7b
First added on: Aug 25, 2024