NCT05229172

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

February 24, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2023

Completed
Last Updated

June 28, 2023

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

November 22, 2021

Last Update Submit

June 27, 2023

Conditions

Respiratory Insufficiency in Children

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (16)

  • 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 - Variability of Peak Inspiratory Pressure (PIP) during Volume Guarantee (VG) ventilation

    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 - Relationship between the set and observed mean airway pressure (MAP) during HFOV

    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

  • +11 more secondary outcomes

Interventions

Volume Targeted VentilationDEVICE

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.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Infants in the intensive care unit setup receiving respiratory support from fabian ventilator with Volume Guarantee (VG) mode active.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with severe airflow obstruction and intracranial hypertension
  • Decision documented to give palliative neonatal care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Medical Center Amsterdam, The Netherlands

Amsterdam, Netherlands

Location

Szpital Położniczo - Ginekologiczny Ujastek

Krakow, Poland

Location

Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego

Poznan, 60-535, Poland

Location

Centre of Postgraduate Medical Education, SPSK im prof.W.Orłowskiego

Warsaw, Poland

Location

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Study Officials

  • Gusztav Belteki, MD, PhD

    Cambridge University Hospitals NHS Trust

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

February 8, 2022

Study Start

February 24, 2022

Primary Completion

April 14, 2023

Study Completion

June 27, 2023

Last Updated

June 28, 2023

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)NL(1)PL(3)