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

NCT05512689 | Completed

• 1 other identifier: 1334/2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung-protective Ventilation; Respiratory Function Monitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Mean value for mask leak and proportion of ventilations with excessive mask leak (defined as >50%) during all ventilations

  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)

  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)

  through study completion, an average of 1 year

• Mean value for ventilation rate (defined as ventilations per minute)

  through study completion, an average of 1 year

• Mean value for peak inflation pressure

  through study completion, an average of 1 year

Study Arms (2)

Control group

NO INTERVENTION

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

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

Interventions

Ventilations while using a respiratory function monitor DEVICE

Healthcare professionals are able to use a feedback device to guide their ventilations.

Interventional group

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Study Officials

• Michael Wagner, MD PhD

  Medical University of Vienna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 23, 2022
• Study Start: January 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)