Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study

Medical University of Vienna

Status: Completed

Conditions: Respiratory Function Monitor; Lung-protective Ventilation

Treatments: Device: Ventilations while using a respiratory function monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05512689

1334/2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Control group

No Intervention group

Description:

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.

Interventional group

Active Comparator group

Description:

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.

Treatment:

Device: Ventilations while using a respiratory function monitor