Respiratory Insufficiency in Children
Conditions
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.
Interventions
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.
Sponsors
Vyaire Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In Conventional Mechanical Ventilation (CMV) with Volume Guarantee (VG) - Relationship between tidal volume set vs tidal volume observed (Volume guarantee mode) | 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 | through study completion, an average of 2 - 4 days | Difference between the set and observed VThf (average and variability) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Mean difference between Pmax and PIP will bereported |
| Ventilator Performance - Relationship between the set and observed mean airway pressure (MAP) during HFOV | through study completion, an average of 2 - 4 days | Difference between the set and observed MAP (average and variability) |
| Ventilator Performance - Relationship between the set and observed Fraction of Inspired Oxygen (FiO2) | through study completion, an average of 2 - 4 days | Difference between the set and observed FiO2 (average and variability) |
| Ventilator Performance - Reason(s) to switch off Volume Guarantee | through study completion, an average of 2 - 4 days | The reason for stopping Volume Guarantee will be documented in the case report form |
| Ventilator Safety - Device failure rate | 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 |
| Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events | through study completion, an average of 2 - 4 days | A summary table presenting number, type and duration of ventilator alarms within study population |
| Ventilator Safety - Number of study participants with device related adverse events | through study completion, an average of 2 - 4 days | Number of malfunction of the investigational device leading to potential or actual patient harm |
| 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 | Difference between set and observed PEEP (average and variability) |
| 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 | Correlation analysis between expired tidal volume and CO2 measurements per patient |
| Exploratory analysis - Feasibility of volumetric capnography | through study completion, an average of 2 - 4 days | A summary table presenting duration, accuracy and availability of volumetric capnography data in neonatal patients |
| 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 | The impact of set ventilator rate and expiratory time on the number of triggered and backup inflations. |
| Analysis of patient-ventilator interactions - analysis of Tidal Volume of triggered and back inflations | through study completion, an average of 2 - 4 days | Tidal volume of triggered and backup ventilator inflations will be analyzed and compared |
| 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 | The impact of ventilator modes and settings will be analyzed and compared |
| Analysis of patient-ventilator interactions - Ventilator-patient asynchronies per patient | 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. |
| 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 | Correlation between average end-tidal CO2 (etCO2)/ transcutaneous CO2 (tcCO2) and blood gas Partial Pressure of Carbon Dioxide (pCO2); Bland-Altman plots |
| Ventilator Performance - Variability of Peak Inspiratory Pressure (PIP) during Volume Guarantee (VG) ventilation | through study completion, an average of 2 - 4 days | Standard deviation of PIP will be reported |
Countries
Netherlands, Poland, United Kingdom
Outcome results
None listed