Prospective Multicenter Observational Study of the Safety and Performance of Fabian Ventilator System Volume Guarantee Mode in Routine Use
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Insufficiency in Children
- Sponsor
- Vyaire Medical
- Enrollment
- 76
- Locations
- 5
- Primary Endpoint
- In Conventional Mechanical Ventilation (CMV) with Volume Guarantee (VG) - Relationship between tidal volume set vs tidal volume observed (Volume guarantee mode)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Ventilator Safety - Number of study participants with device related adverse events(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(through study completion, an average of 2 - 4 days)
- Ventilator Performance - Variability of Peak Inspiratory Pressure (PIP) during Volume Guarantee (VG) ventilation(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(through study completion, an average of 2 - 4 days)
- Analysis of patient-ventilator interactions - analysis of Tidal Volume of triggered and back inflations(through study completion, an average of 2 - 4 days)
- Ventilator Performance - Relationship between the set and observed Positive End-Expiratory Pressure (PEEP) and Continuous Positive Airway Pressure (CPAP)(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)(through study completion, an average of 2 - 4 days)
- Ventilator Performance - Reason(s) to switch off Volume Guarantee(through study completion, an average of 2 - 4 days)
- Ventilator Performance - Relationship between the set and observed Fraction of Inspired Oxygen (FiO2)(through study completion, an average of 2 - 4 days)
- Ventilator Safety - Device failure rate(through study completion, an average of 2 - 4 days)
- Ventilator Performance - Relationship between the set and observed mean airway pressure (MAP) during HFOV(through study completion, an average of 2 - 4 days)
- Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events(through study completion, an average of 2 - 4 days)
- Exploratory analysis - Feasibility of volumetric capnography(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(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(through study completion, an average of 2 - 4 days)
- Analysis of patient-ventilator interactions - Ventilator-patient asynchronies per patient(through study completion, an average of 2 - 4 days)