Lung-protective VentilationNCT05512689
Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study
A study testing Ventilations while using a respiratory function monitor in people with Lung-protective Ventilation and Respiratory Function Monitor, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Lung-protective Ventilation, Respiratory Function Monitor
- What is being tested?
- Ventilations while using a respiratory function monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- Healthcare professionals or parents/legal guardians, representing their children, that do not consent to participation in this study
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Being tested
- Ventilations while using a respiratory function monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilations while using a respiratory function monitorDevice
Healthcare professionals are able to use a feedback device to guide their ventilations.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ventilations while using a respiratory function monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of ventilations with VTe between 4-8ml/kg
percentage of ventilations within range divided through all ventilations performed, for each participant
Measured: 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
defined as > 50%
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
Mean value for ventilation rate (defined as ventilations per minute)
defined as ventilations per minute
Measured: through study completion, an average of 1 year
Mean value for peak inflation pressure
defined as > 35 cmH2O
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Jan 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung-protective VentilationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Wagner, Medical University of Vienna
- Investigators
- Michael Wagner, MD PhD, Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512689
- Sponsor's protocol ID
- 1334/2022
- Status last verified
- Nov 2023
- First submitted
- 18 Aug 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study
- ClinicalTrials.gov ID
- NCT05512689
- Acronym / sponsor ID
- 1334/2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Ventilations while using a respiratory function monitorIn the interventional group, healthcare professionals will ventilate the infants using the RFM and are able to adapt their ventilations according to the RFM feedback. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Healthcare professionals or parents/legal guardians, representing their children, that do not consent to participation in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilations while using a respiratory function monitorHealthcare professionals are able to use a feedback device to guide their ventilations. | Device | Interventional group |
Primary outcome
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
10 secondary outcomes
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
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
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
Mean value for ventilation rate (defined as ventilations per minute)
Time frame: through study completion, an average of 1 year
Mean value for peak inflation pressure
Time frame: through study completion, an average of 1 year
Outcome data and adverse events
Time frame: through study completion, an average of 1 year
Comparison of elective versus delivery room interventions
Time frame: through study completion, an average of 1 year
Comparison of fellows vs. consultants
Time frame: through study completion, an average of 1 year
Comparison of sef-inflating-bag vs. neo-T
Time frame: through study completion, an average of 1 year
Comparison of ventilations via face mask vs. endotracheal tube
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No. IPD will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wagner, MD PhD study director
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilations while using a respiratory function monitor in people with Lung-protective Ventilation and Respiratory Function Monitor, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of ventilations with VTe between 4-8ml/kg (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.