Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Insufficiency in Children

Intervention / Treatment
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* Device: Volume Targeted Ventilation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Volume Targeted Ventilation|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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | through study completion, an average of 2 - 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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. | through study completion, an average of 2 - 4 days |