An interventional study of Ventilations while using a respiratory function monitor in Lung-protective Ventilation and Respiratory Function Monitor, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged Up to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Prevention
This study was a non-blinded, non-randomized intervention study in a single-center clinical setting, analyzing ventilation quality with and without RFM visibility.
The study was conducted at the Neonatal Intensive Care Unit and the delivery room at the Division of Neonatology, at the Medical University of Vienna.
We aimed to record ventilation parameters (tidal volume, mask leak, ventilation rate, PIP, PEEP) using a CE-certified Respiratory Function Monitor (Neo100, Monivent AB, Gothenburg, Sweden), which was either hidden or visible to the provider responsible for the airway (airway provider), during ventilations on term and preterm patients at the NICU and the delivery room.
The investigators aimed to determine the quality of ventilations performed by healthcare professionals depending on RFM visibility. Analysis occurred, determining whether observing the data displayed on the RFM during PPV of preterm and newborn infants lead to adjustments in applied pressure and an increase in the proportion of inflations performed within a predefined range of 4-8 ml/kg for VTe.
The investigators hypothesized that using a RFM with numeric and graphical display of values during positive pressure ventilation of infants will lead to i) more frequent recognition and correction of tidal volumes outside the predefined range and ii) reduction of mask leak.
This knowledge gain may improve future training using a RFM to improve the quality of ventilations and, thereby, patient safety.
Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the control group, the healthcare professional ventilates the infants without any feedback about the ventilation. This represents the normal clinical setting. The RFM will be recording data on the ventilation quality.
In the interventional group, healthcare professionals will ventilate the infants using the RFM and are able to adapt their ventilations according to the RFM feedback.
Device: Ventilations while using a respiratory function monitor
Healthcare professionals are able to use a feedback device to guide their ventilations.
Proportion of ventilations with VTe between 4-8ml/kg
percentage of ventilations within range divided through all ventilations performed, for each participant
Time frame: through study completion, an average of 1 year
Mean value for mask leak and proportion of ventilations with excessive mask leak (defined as >50%) during all ventilations
defined as \> 50%
Time frame: through study completion, an average of 1 year
Occurrence of insufficient tidal volume (defined as <4mL/kg) as a proportion of ventilations given (face mask and endotracheal tube)
defined as \< 4ml/kg
Time frame: through study completion, an average of 1 year
Occurrence of excessive tidal volume (defined as >8mL/kg) as a proportion of ventilations given (face mask and endotracheal tube)
defined as \> 8ml/kg
Time frame: through study completion, an average of 1 year
Mean value for ventilation rate (defined as ventilations per minute)
defined as ventilations per minute
Time frame: through study completion, an average of 1 year
Mean value for peak inflation pressure
defined as \> 35 cmH2O
Time frame: through study completion, an average of 1 year
Outcome data and adverse events
this included diagnoses (i.e., bronchopulmonary dysplasia \[BPD\], persistent ductus arteriosus \[PDA\], IVH, periventricular leukomalacia \[PVL\], and pneumothorax) and the time frame of occurrence (within 24 hours, one week, or during the total hospital stay). BPD was defined as the need of any respiratory support at the GA of 36 weeks, evaluated for infants below 32+0 weeks GA. IVH was determined using the DEGUM classification
Time frame: through study completion, an average of 1 year
Comparison of elective versus delivery room interventions
mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison
Time frame: through study completion, an average of 1 year
Comparison of fellows vs. consultants
mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison
Time frame: through study completion, an average of 1 year
Comparison of sef-inflating-bag vs. neo-T
mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison
Time frame: through study completion, an average of 1 year
Comparison of ventilations via face mask vs. endotracheal tube
mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison
Time frame: through study completion, an average of 1 year
Plan to share: No — IPD will not be made available to other researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Vienna