Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG) (PaVoG)

June 27, 2023 updated by: Vyaire Medical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • University Medical Center Amsterdam, The Netherlands
  • Poland
      • Kraków, Poland
        • Szpital Położniczo - Ginekologiczny Ujastek
      • Poznań, Poland, 60-535
        • Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego
      • Warsaw, Poland
        • Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego
  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

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)
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
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
Time Frame: through study completion, an average of 2 - 4 days
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)
Time Frame: through study completion, an average of 2 - 4 days
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
Time Frame: through study completion, an average of 2 - 4 days
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)
Time Frame: through study completion, an average of 2 - 4 days
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
Time Frame: through study completion, an average of 2 - 4 days
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)
Time Frame: through study completion, an average of 2 - 4 days
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
Time Frame: through study completion, an average of 2 - 4 days
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
Time Frame: 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
through study completion, an average of 2 - 4 days
Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events
Time Frame: through study completion, an average of 2 - 4 days
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
Time Frame: through study completion, an average of 2 - 4 days
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
Time Frame: 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
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
Time Frame: through study completion, an average of 2 - 4 days
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
Time Frame: through study completion, an average of 2 - 4 days
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
Time Frame: 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.
through study completion, an average of 2 - 4 days
Analysis of patient-ventilator interactions - analysis of Tidal Volume of triggered and back inflations
Time Frame: through study completion, an average of 2 - 4 days
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
Time Frame: through study completion, an average of 2 - 4 days
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
Time Frame: 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.
through study completion, an average of 2 - 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vyaire Medical

Investigators

  • Study Chair: Gusztav Belteki, MD, PhD, Cambridge University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2022

Primary Completion (Actual)

April 14, 2023

Study Completion (Actual)

June 27, 2023

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-21-003-PaVoG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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