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Completed

NCT Number: NCT05512689

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.

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Key information

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventilations while using a respiratory function monitor

Device

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

Primary outcomes

  1. Proportion of ventilations with VTe between 4-8ml/kg

    Time frame: through study completion, an average of 1 year

    percentage of ventilations within range divided through all ventilations performed, for each participant

Secondary outcomes

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

    Time frame: through study completion, an average of 1 year

    defined as > 50%

  2. Occurrence of insufficient tidal volume (defined as <4mL/kg) as a proportion of ventilations given (face mask and endotracheal tube)

    Time frame: through study completion, an average of 1 year

    defined as < 4ml/kg

  3. Occurrence of excessive tidal volume (defined as >8mL/kg) as a proportion of ventilations given (face mask and endotracheal tube)

    Time frame: through study completion, an average of 1 year

    defined as > 8ml/kg

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

    Time frame: through study completion, an average of 1 year

    defined as ventilations per minute

  5. Mean value for peak inflation pressure

    Time frame: through study completion, an average of 1 year

    defined as > 35 cmH2O

  6. Outcome data and adverse events

    Time frame: through study completion, an average of 1 year

    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

  7. Comparison of elective versus delivery room interventions

    Time frame: through study completion, an average of 1 year

    mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison

  8. Comparison of fellows vs. consultants

    Time frame: through study completion, an average of 1 year

    mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison

  9. Comparison of sef-inflating-bag vs. neo-T

    Time frame: through study completion, an average of 1 year

    mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison

  10. Comparison of ventilations via face mask vs. endotracheal tube

    Time frame: through study completion, an average of 1 year

    mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2022
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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