Respiratory Insufficiency in ChildrenPaVoGNCT05229172
Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG)
An observational study of Respiratory Insufficiency in Children, run by Vyaire Medical at 5 sites in 3 countries.
Trial summary
This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product and will provide performance data on the Volume Guarantee function of the fabian ventilator in daily clinical routine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Insufficiency in Children
- What is being tested?
- Volume Targeted Ventilation
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 24 Feb 2022to 27 Jun 2023
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Infants in the intensive care unit setup receiving respiratory support from fabian ventilator with Volume Guarantee (VG) mode active.
Who may be able to join
- Patient ventilated with fabian ventilator (conventional or HFOV) with VG mode active.
- The anticipated use of VG mode is at least 12 hours
- Informed Consent given by parents or guardians according to the process approved by the local research ethical committee
Who cannot join
- Patients with severe airflow obstruction and intracranial hypertension
- Decision documented to give palliative neonatal care.
- The clinical care team does not agree with inclusion of the infant to the study
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Poland3 sites
Szpital Położniczo - Ginekologiczny Ujastek
Krakow
Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan, 60-535
Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego
Warsaw
Netherlands1 site
University Medical Center Amsterdam, The Netherlands
Amsterdam
United Kingdom1 site
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Prospective Multicenter Observational Study of the Safety and Performance of Fabian Ventilator System Volume Guarantee Mode in Routine Use
This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product and will provide performance data on the Volume Guarantee function of the fabian ventilator in daily clinical routine.
Read the detailed description
PaVoG study is a prospective, multicenter, single-cohort post market observational study.
The study procedures will be conducted according to standard of care of each participating hospital and the instructions for use of the study device.
To allow data collection, an Informed Consent Form will be obtained from each study participant/ legally authorized representative, if required by the local Ethical Committee. Ventilator data will be recorded in the hospital's data capture system or on a study laptop provided by the Sponsor.
Each patient will be clinically evaluated according to hospital standard of care. If inclusion and exclusion criteria are met, and the investigative team is available the patient will be enrolled.
Study duration for an individual patient will differ, depending on the time spent on fabian ventilator with Volume Guarantee mode on.
It is anticipated that for most will be between 2-4 days.
- Conditions
- Respiratory Insufficiency in Children
- Being tested
- Volume Targeted Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume Targeted VentilationDevice
There is no study specific intervention planned. Procedures will be conducted according to standard of care of each participating hospital and the instructions for use of the study device.
What is being measured
The primary outcome is the main question the study is designed to answer.
In Conventional Mechanical Ventilation (CMV) with Volume Guarantee (VG) - Relationship between tidal volume set vs tidal volume observed (Volume guarantee mode)
Difference between set and observed expired tidal volume (VTe), average - on the patient level and breath-to-breath variability will be reported
Measured: through study completion, an average of 2 - 4 days
In High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG)- Relationship between the set and observed tidal volume of oscillations (VThf) during HFOV-VG
Difference between the set and observed VThf (average and variability)
Measured: through study completion, an average of 2 - 4 days
Secondary outcomes (16)
Ventilator Performance - Relationship between the set and observed Positive End-Expiratory Pressure (PEEP) and Continuous Positive Airway Pressure (CPAP)
Difference between set and observed PEEP (average and variability)
Measured: through study completion, an average of 2 - 4 days
Ventilator Performance - Variability of Peak Inspiratory Pressure (PIP) during Volume Guarantee (VG) ventilation
Standard deviation of PIP will be reported
Measured: through study completion, an average of 2 - 4 days
Ventilator Performance - Relationship of Peak Inspiratory Pressure (PIP) during Volume Guarantee (VG) ventilation to the set maximum allowed inflating pressure (Pmax)
Mean difference between Pmax and PIP will bereported
Measured: through study completion, an average of 2 - 4 days
Ventilator Performance - Relationship between the set and observed mean airway pressure (MAP) during HFOV
Difference between the set and observed MAP (average and variability)
Measured: through study completion, an average of 2 - 4 days
Ventilator Performance - Relationship between the set and observed Fraction of Inspired Oxygen (FiO2)
Difference between the set and observed FiO2 (average and variability)
Measured: through study completion, an average of 2 - 4 days
Ventilator Performance - Reason(s) to switch off Volume Guarantee
The reason for stopping Volume Guarantee will be documented in the case report form
Measured: through study completion, an average of 2 - 4 days
Ventilator Safety - Device failure rate
Malfunction of the investigational device necessitating removal of a neonate to another ventilation mode or ventilator
Measured: through study completion, an average of 2 - 4 days
Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events
A summary table presenting number, type and duration of ventilator alarms within study population
Measured: through study completion, an average of 2 - 4 days
Ventilator Safety - Number of study participants with device related adverse events
Number of malfunction of the investigational device leading to potential or actual patient harm
Measured: through study completion, an average of 2 - 4 days
Exploratory analysis - Relationship between end-tidal CO2 (etCO2) or transcutaneous CO2 (tcCO2) and Partial Pressure of Carbon Dioxide (pCO2) in blood gases (capillary and arterial) in infants of different clinical characteristics
Correlation between average end-tidal CO2 (etCO2)/ transcutaneous CO2 (tcCO2) and blood gas Partial Pressure of Carbon Dioxide (pCO2); Bland-Altman plots
Measured: through study completion, an average of 2 - 4 days
Exploratory analysis - Relationship between expired tidal volume (VTe) or Minute Volume (MV) and end-tidal CO2 (etCO2) or Partial Pressure of Carbon Dioxide (pCO2) or transcutaneous CO2 (tcCO2) in infants of different clinical characteristics
Correlation analysis between expired tidal volume and CO2 measurements per patient
Measured: through study completion, an average of 2 - 4 days
Exploratory analysis - Feasibility of volumetric capnography
A summary table presenting duration, accuracy and availability of volumetric capnography data in neonatal patients
Measured: through study completion, an average of 2 - 4 days
Analysis of patient-ventilator interactions - Analysis of number of triggered and backup ventilator inflations per patient
The impact of set ventilator rate and expiratory time on the number of triggered and backup inflations.
Measured: through study completion, an average of 2 - 4 days
Analysis of patient-ventilator interactions - analysis of Tidal Volume of triggered and back inflations
Tidal volume of triggered and backup ventilator inflations will be analyzed and compared
Measured: through study completion, an average of 2 - 4 days
Analysis of patient-ventilator interactions - Contribution of the infant to the total minute ventilation via spontaneous breathing between ventilator inflations per patient
The impact of ventilator modes and settings will be analyzed and compared
Measured: through study completion, an average of 2 - 4 days
Analysis of patient-ventilator interactions - Ventilator-patient asynchronies per patient
The occurrence and frequency of inspiratory hold during time cycled ventilation. The frequency of interrupted expirations. Occurrence and frequency of incomplete expiration during neonatal ventilation. Calculation of asynchrony index per patient and for study population.
Measured: through study completion, an average of 2 - 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start24 Feb 2022
- Primary completion14 Apr 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Insufficiency in ChildrenStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyaire Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gusztav Belteki, MD, PhD, Study chair, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229172
- Sponsor's protocol ID
- CS-21-003-PaVoG
- Acronym
- PaVoG
- Status last verified
- Jan 2022
- First submitted
- 22 Nov 2021
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Study of the Safety and Performance of Fabian Ventilator System Volume Guarantee Mode in Routine Use
- ClinicalTrials.gov ID
- NCT05229172
- Acronym / sponsor ID
- PaVoG / CS-21-003-PaVoG
- Conditions
- Respiratory Insufficiency in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Vyaire MedicalIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 8 Feb 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 is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product and will provide performance data on the Volume Guarantee function of the fabian ventilator in daily clinical routine.
Detailed description
PaVoG study is a prospective, multicenter, single-cohort post market observational study.
The study procedures will be conducted according to standard of care of each participating hospital and the instructions for use of the study device.
To allow data collection, an Informed Consent Form will be obtained from each study participant/ legally authorized representative, if required by the local Ethical Committee. Ventilator data will be recorded in the hospital's data capture system or on a study laptop provided by the Sponsor.
Each patient will be clinically evaluated according to hospital standard of care. If inclusion and exclusion criteria are met, and the investigative team is available the patient will be enrolled.
Study duration for an individual patient will differ, depending on the time spent on fabian ventilator with Volume Guarantee mode on.
It is anticipated that for most will be between 2-4 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Infants in the intensive care unit setup receiving respiratory support from fabian ventilator with Volume Guarantee (VG) mode active.
Key inclusion criteria (3 listed)
- Patient ventilated with fabian ventilator (conventional or HFOV) with VG mode active.
- The anticipated use of VG mode is at least 12 hours
- Informed Consent given by parents or guardians according to the process approved by the local research ethical committee
Key exclusion criteria (3 listed)
- Patients with severe airflow obstruction and intracranial hypertension
- Decision documented to give palliative neonatal care.
- The clinical care team does not agree with inclusion of the infant to the 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 |
|---|---|---|
| Volume Targeted VentilationThere is no study specific intervention planned. Procedures will be conducted according to standard of care of each participating hospital and the instructions for use of the study device. | Device | – |
Primary outcome
In Conventional Mechanical Ventilation (CMV) with Volume Guarantee (VG) - Relationship between tidal volume set vs tidal volume observed (Volume guarantee mode)
Time frame: through study completion, an average of 2 - 4 days
Difference between set and observed expired tidal volume (VTe), average - on the patient level and breath-to-breath variability will be reported
In High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG)- Relationship between the set and observed tidal volume of oscillations (VThf) during HFOV-VG
Time frame: through study completion, an average of 2 - 4 days
Difference between the set and observed VThf (average and variability)
16 secondary outcomes
Ventilator Performance - Relationship between the set and observed Positive End-Expiratory Pressure (PEEP) and Continuous Positive Airway Pressure (CPAP)
Time frame: through study completion, an average of 2 - 4 days
Ventilator Performance - Variability of Peak Inspiratory Pressure (PIP) during Volume Guarantee (VG) ventilation
Time frame: through study completion, an average of 2 - 4 days
Ventilator Performance - Relationship of Peak Inspiratory Pressure (PIP) during Volume Guarantee (VG) ventilation to the set maximum allowed inflating pressure (Pmax)
Time frame: through study completion, an average of 2 - 4 days
Ventilator Performance - Relationship between the set and observed mean airway pressure (MAP) during HFOV
Time frame: through study completion, an average of 2 - 4 days
Ventilator Performance - Relationship between the set and observed Fraction of Inspired Oxygen (FiO2)
Time frame: through study completion, an average of 2 - 4 days
Ventilator Performance - Reason(s) to switch off Volume Guarantee
Time frame: through study completion, an average of 2 - 4 days
Ventilator Safety - Device failure rate
Time frame: through study completion, an average of 2 - 4 days
Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events
Time frame: through study completion, an average of 2 - 4 days
Ventilator Safety - Number of study participants with device related adverse events
Time frame: through study completion, an average of 2 - 4 days
Exploratory analysis - Relationship between end-tidal CO2 (etCO2) or transcutaneous CO2 (tcCO2) and Partial Pressure of Carbon Dioxide (pCO2) in blood gases (capillary and arterial) in infants of different clinical characteristics
Time frame: through study completion, an average of 2 - 4 days
Exploratory analysis - Relationship between expired tidal volume (VTe) or Minute Volume (MV) and end-tidal CO2 (etCO2) or Partial Pressure of Carbon Dioxide (pCO2) or transcutaneous CO2 (tcCO2) in infants of different clinical characteristics
Time frame: through study completion, an average of 2 - 4 days
Exploratory analysis - Feasibility of volumetric capnography
Time frame: through study completion, an average of 2 - 4 days
Analysis of patient-ventilator interactions - Analysis of number of triggered and backup ventilator inflations per patient
Time frame: through study completion, an average of 2 - 4 days
Analysis of patient-ventilator interactions - analysis of Tidal Volume of triggered and back inflations
Time frame: through study completion, an average of 2 - 4 days
Analysis of patient-ventilator interactions - Contribution of the infant to the total minute ventilation via spontaneous breathing between ventilator inflations per patient
Time frame: through study completion, an average of 2 - 4 days
Analysis of patient-ventilator interactions - Ventilator-patient asynchronies per patient
Time frame: through study completion, an average of 2 - 4 days
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 28 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Gusztav Belteki, MD, PhD study chair
Cambridge University Hospitals NHS Foundation Trust
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency in Children, run by Vyaire Medical at 5 sites in 3 countries.
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 3 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland, Netherlands, United Kingdom. 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?
In Conventional Mechanical Ventilation (CMV) with Volume Guarantee (VG) - Relationship between tidal volume set vs tidal volume observed (Volume guarantee mode) (time frame: through study completion, an average of 2 - 4 days). The study lists 2 primary outcomes in all. 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 28 Jun 2023.