Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG)

Respiratory Insufficiency in Children Clinical Trial

— PaVoG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229172
• Other study ID #: CS-21-003-PaVoG
• Status: Completed
• Start date: February 24, 2022
• Est. completion date: June 27, 2023

Study information

• Verified date: January 2022
• Source: Vyaire Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 27, 2023
• Est. primary completion date: April 14, 2023
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Insufficiency
• Respiratory Insufficiency in Children

Intervention

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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Amsterdam, The Netherlands	Amsterdam
Poland	Szpital Polozniczo - Ginekologiczny Ujastek	Kraków
Poland	Ginekologiczno-Polozniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego	Poznan
Poland	Centre of Postgraduate Medical Education, SPSK im prof.W.Orlowskiego	Warsaw
United Kingdom	John Radcliffe Hospital	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Vyaire Medical

Countries where clinical trial is conducted

Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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