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

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

Study Overview

• Status: Completed
• Conditions: Lung-protective Ventilation; Respiratory Function Monitor
• Intervention / Treatment: Device: Ventilations while using a respiratory function monitor

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 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; 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.

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Study Director: Michael Wagner, MD PhD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 20, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1334/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No