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

NCT ID: NCT05512689

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-03-01

Brief Summary

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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

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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.

Conditions

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Lung-protective Ventilation Respiratory Function Monitor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Ventilations while using a respiratory function monitor

Intervention Type DEVICE

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

Interventions

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Ventilations while using a respiratory function monitor

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

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Michael Wagner

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Wagner, MD PhD

Role: STUDY_DIRECTOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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1334/2022

Identifier Type: -

Identifier Source: org_study_id