Clinical trial NCT05229172: Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG)
Official title: Prospective Multicenter Observational Study of the Safety and Performance of Fabian Ventilator System Volume Guarantee Mode in Routine Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency in Children
Lead sponsor: Vyaire Medical
Sponsor class: INDUSTRY
First posted: 2022-02-08
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants in the intensive care unit setup receiving respiratory support from fabian ventilator with Volume Guarantee (VG) mode active.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: In Conventional Mechanical Ventilation (CMV) with Volume Guarantee (VG) - Relationship between tidal volume set vs tidal volume observed (Volume guarantee mode)
timeFrame: through study completion, an average of 2 - 4 days
measure: In High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG)- Relationship between the set and observed tidal volume of oscillations (VThf) during HFOV-VG
timeFrame: through study completion, an average of 2 - 4 days
Secondary outcomes:
measure: Ventilator Performance - Relationship between the set and observed Positive End-Expiratory Pressure (PEEP) and Continuous Positive Airway Pressure (CPAP)
timeFrame: through study completion, an average of 2 - 4 days
measure: Ventilator Performance - Variability of Peak Inspiratory Pressure (PIP) during Volume Guarantee (VG) ventilation
timeFrame: through study completion, an average of 2 - 4 days
measure: Ventilator Performance - Relationship of Peak Inspiratory Pressure (PIP) during Volume Guarantee (VG) ventilation to the set maximum allowed inflating pressure (Pmax)
timeFrame: through study completion, an average of 2 - 4 days
measure: Ventilator Performance - Relationship between the set and observed mean airway pressure (MAP) during HFOV
timeFrame: through study completion, an average of 2 - 4 days
measure: Ventilator Performance - Relationship between the set and observed Fraction of Inspired Oxygen (FiO2)
timeFrame: through study completion, an average of 2 - 4 days
measure: Ventilator Performance - Reason(s) to switch off Volume Guarantee
timeFrame: through study completion, an average of 2 - 4 days
measure: Ventilator Safety - Device failure rate
timeFrame: through study completion, an average of 2 - 4 days
measure: Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events
timeFrame: through study completion, an average of 2 - 4 days
measure: Ventilator Safety - Number of study participants with device related adverse events
timeFrame: through study completion, an average of 2 - 4 days
measure: 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
timeFrame: through study completion, an average of 2 - 4 days
measure: 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
timeFrame: through study completion, an average of 2 - 4 days
measure: Exploratory analysis - Feasibility of volumetric capnography
timeFrame: through study completion, an average of 2 - 4 days
measure: Analysis of patient-ventilator interactions - Analysis of number of triggered and backup ventilator inflations per patient
timeFrame: through study completion, an average of 2 - 4 days
measure: Analysis of patient-ventilator interactions - analysis of Tidal Volume of triggered and back inflations
timeFrame: through study completion, an average of 2 - 4 days
measure: Analysis of patient-ventilator interactions - Contribution of the infant to the total minute ventilation via spontaneous breathing between ventilator inflations per patient
timeFrame: through study completion, an average of 2 - 4 days
measure: Analysis of patient-ventilator interactions - Ventilator-patient asynchronies per patient
timeFrame: through study completion, an average of 2 - 4 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: University Medical Center Amsterdam, The Netherlands
city: Kraków
country: Poland
facility: Szpital Położniczo - Ginekologiczny Ujastek
city: Poznań
country: Poland
facility: Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego
city: Warsaw
country: Poland
facility: Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: Cambridge University Hospitals NHS Trust
name: Gusztav Belteki, MD, PhD
role: STUDY_CHAIR
References: