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Completed

NCT Number: NCT05229172

Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG)

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.

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Key information

Conditions

Respiratory Insufficiency in Children

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Amsterdam, The Netherlands, Amsterdam, Netherlands

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About this study

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.

Who can participate

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Volume Targeted Ventilation

Device

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.

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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

    Difference between set and observed PEEP (average and variability)

  2. Ventilator Performance - Variability of Peak Inspiratory Pressure (PIP) during Volume Guarantee (VG) ventilation

    Time frame: through study completion, an average of 2 - 4 days

    Standard deviation of PIP will be reported

  3. 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

    Mean difference between Pmax and PIP will bereported

  4. 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

    Difference between the set and observed MAP (average and variability)

  5. Ventilator Performance - Relationship between the set and observed Fraction of Inspired Oxygen (FiO2)

    Time frame: through study completion, an average of 2 - 4 days

    Difference between the set and observed FiO2 (average and variability)

  6. Ventilator Performance - Reason(s) to switch off Volume Guarantee

    Time frame: through study completion, an average of 2 - 4 days

    The reason for stopping Volume Guarantee will be documented in the case report form

  7. Ventilator Safety - Device failure rate

    Time frame: through study completion, an average of 2 - 4 days

    Malfunction of the investigational device necessitating removal of a neonate to another ventilation mode or ventilator

  8. Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events

    Time frame: through study completion, an average of 2 - 4 days

    A summary table presenting number, type and duration of ventilator alarms within study population

  9. Ventilator Safety - Number of study participants with device related adverse events

    Time frame: through study completion, an average of 2 - 4 days

    Number of malfunction of the investigational device leading to potential or actual patient harm

  10. 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

    Correlation between average end-tidal CO2 (etCO2)/ transcutaneous CO2 (tcCO2) and blood gas Partial Pressure of Carbon Dioxide (pCO2); Bland-Altman plots

  11. 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

    Correlation analysis between expired tidal volume and CO2 measurements per patient

  12. Exploratory analysis - Feasibility of volumetric capnography

    Time frame: through study completion, an average of 2 - 4 days

    A summary table presenting duration, accuracy and availability of volumetric capnography data in neonatal patients

  13. 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

    The impact of set ventilator rate and expiratory time on the number of triggered and backup inflations.

  14. 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

    Tidal volume of triggered and backup ventilator inflations will be analyzed and compared

  15. 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

    The impact of ventilator modes and settings will be analyzed and compared

  16. Analysis of patient-ventilator interactions - Ventilator-patient asynchronies per patient

    Time frame: through study completion, an average of 2 - 4 days

    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.

Sponsors and collaborators

Lead sponsor

Vyaire Medical

Industry

Registry information

Official study title

Prospective Multicenter Observational Study of the Safety and Performance of Fabian Ventilator System Volume Guarantee Mode in Routine Use

Acronym: PaVoG

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2022
Registry last updated
Jun 28, 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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