Clinical trial NCT05512689: Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study
Official title: Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung-protective Ventilation
Respiratory Function Monitor
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 90
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: We aimed to avoid classical randomization due to a possible learning and habituation effect from the feedback when using the RFM. We started with a phase of routine ventilation, in which the healthcare professional ventilated the infants using the RFM but did not receive any feedback about the ventilation. This represents the normal clinical setting. In the second phase, the healthcare professional then received visual feedback from the RFM during ventilations. The healthcare professional could then adjust his ventilation technique in real time.
Primary purpose: PREVENTION

Brief summary: This study was a non-blinded, non-randomized intervention study in a single-center clinical setting, analyzing ventilation quality with and without RFM visibility.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients at the Neonatal Intensive Care Unit (NICU) and in the delivery room who receive positive pressure ventilation
* Written consent from parents or legal guardians of patients
* Preterm and term infants (male and female, any gestational age)

Exclusion Criteria:

- Healthcare professionals or parents/legal guardians, representing their children, that do not consent to participation in this study

Primary outcomes:
measure: Proportion of ventilations with VTe between 4-8ml/kg
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Mean value for mask leak and proportion of ventilations with excessive mask leak (defined as >50%) during all ventilations
timeFrame: through study completion, an average of 1 year
measure: Occurrence of insufficient tidal volume (defined as <4mL/kg) as a proportion of ventilations given (face mask and endotracheal tube)
timeFrame: through study completion, an average of 1 year
measure: Occurrence of excessive tidal volume (defined as >8mL/kg) as a proportion of ventilations given (face mask and endotracheal tube)
timeFrame: through study completion, an average of 1 year
measure: Mean value for ventilation rate (defined as ventilations per minute)
timeFrame: through study completion, an average of 1 year
measure: Mean value for peak inflation pressure
timeFrame: through study completion, an average of 1 year
measure: Outcome data and adverse events
timeFrame: through study completion, an average of 1 year
measure: Comparison of elective versus delivery room interventions
timeFrame: through study completion, an average of 1 year
measure: Comparison of fellows vs. consultants
timeFrame: through study completion, an average of 1 year
measure: Comparison of sef-inflating-bag vs. neo-T
timeFrame: through study completion, an average of 1 year
measure: Comparison of ventilations via face mask vs. endotracheal tube
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Michael Wagner, MD PhD
role: STUDY_DIRECTOR
References: