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

Study Overview
=================
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.

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

Conditions
-----------------
Lung-protective Ventilation, Respiratory Function Monitor

Intervention / Treatment
-----------------
* Device: Ventilations while using a respiratory function monitor


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>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. | |
| Active Comparator: Interventional group<br>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<br>* Healthcare professionals are able to use a feedback device to guide their ventilations.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of ventilations with VTe between 4-8ml/kg | percentage of ventilations within range divided through all ventilations performed, for each participant | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean value for mask leak and proportion of ventilations with excessive mask leak (defined as >50%) during all ventilations | defined as > 50% | 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 | 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 | through study completion, an average of 1 year | 
| Mean value for ventilation rate (defined as ventilations per minute) | defined as ventilations per minute | through study completion, an average of 1 year | 
| Mean value for peak inflation pressure | defined as > 35 cmH2O | 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 | 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 | 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 | 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 | 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 | through study completion, an average of 1 year |