Ignite Creation Date:
2024-05-06 @ 2:33 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04355754
Status:
UNKNOWN
Last Update Posted:
2020-04-27
First Post:
2020-04-16
Brief Title:
Ventil Device Usefulness in Mechanically Ventilated ICU Patients
Sponsor:
Medical University of Gdansk
Organization:
Medical University of Gdansk
Study Overview
Official Title:
Assesment of Usefulness of Ventil Device for Mechanical Ventilation in ICU Patients
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
During Covid-19 pandemic many patients require mechanical ventilation due to disastrous impact of SARS-CoV-2 on lungs In several countries there is a shortage of ICU beds and ventilators Critically ill patients are treated outside ICUs Doctors are facing ethical dilemmas who they should treat with ventilation who should receive ventilator and who should but will not In ICUs or step down units or in nursery homes there are also patients beyond hope treated - very often they are dependent on mechanical ventilation Some attempts to invent a device that could replace complex machines in patients with anticipated poor outcome have been made Ventil was used in clinical scenarios for separate lung ventilation with good effect As a flow divider it has a potential to ventilate 2 patients at the same time In the study Ventil will ventilate one patient and instead of the second there will be an artificial lung Tidal volumes minute ventilation PEEP set and final will be checked Ppeak Pmean Pplat Cdyn airway resistance EtCO2 Sat O2 HR SAP DAP will be monitored every 2 hrs as well as blood-gas analysis every 8 hrs
Detailed Description:
During Covid-19 pandemic many patients require mechanical ventilation due to disastrous impact of SARS-CoV-2 on lungs In several countries there is a shortage of ICU beds and ventilators Critically ill patients are treated outside ICUs Doctors are facing ethical dilemmas who they should treat with ventilation who should receive ventilator and who should but will not
Before pandemic in ICUs there had always been patients who required mechanical ventilation because of extrapulmonary reasons as well as palliative cases or those in vegetative condition Most of these patients require just a simple ventilator not a sophisticated mode of ventilation Some attempts to invent a device that could replace complex machines in patients with anticipated poor outcome have been made Ventil was used in clinical scenarios for separate lung ventilation with good effect VENTIL device a flow divider theoretically allows for independent fully automated synchronous ventilation of 2 patients with use of only one respirator In the shortage of respirators ex terrorist attack natural disasters device allows also to ventilate in classical system two patients using single respirator
Ventil - independent lung ventilation system was constructed by engineers from Nalecz Institute of Biocybernetics and Biomedical Engineering of Polish Academy of Science Ventil was tested in the clinical scenario - its safety had been confirmed Several years ago the working prototypes of the device after approval of Ethical Committee was tested in about 150 patients who were ventilated with independent synchronous lung ventilation and had been found useful
The idea of the study is to check the usefulness of the device modern version in ICU patients who can be ventilated with volume -controlled mode of ventilation as an attempt to use single device for ventilation of 2 patients At this moment according to several scientific societies sharing mechanical ventilators should not be attempted because it cannot be done safely with current equipment However it is possible that using a designed flow divider will allow safe ventilation in patients without needs for complicated modes of ventilation Then maybe it will be possible to release some ventilators and to use them in patients in severe condition mainly in the era of extreme ventilator shortage In the study Ventil will ventilate one patient and instead of the second there will be an artificial lung Tidal volumes minute ventilation PEEP set and final will be checked Ppeak Pmean Pplat Cdyn airway resistance EtCO2 Sat O2 HR SAP DAP will be monitored every 2 hrs as well as blood-gas analysis every 8 hrs
Before pandemic in ICUs there had always been patients who required mechanical ventilation because of extrapulmonary reasons as well as palliative cases or those in vegetative condition Most of these patients require just a simple ventilator not a sophisticated mode of ventilation Some attempts to invent a device that could replace complex machines in patients with anticipated poor outcome have been made Ventil was used in clinical scenarios for separate lung ventilation with good effect VENTIL device a flow divider theoretically allows for independent fully automated synchronous ventilation of 2 patients with use of only one respirator In the shortage of respirators ex terrorist attack natural disasters device allows also to ventilate in classical system two patients using single respirator
Ventil - independent lung ventilation system was constructed by engineers from Nalecz Institute of Biocybernetics and Biomedical Engineering of Polish Academy of Science Ventil was tested in the clinical scenario - its safety had been confirmed Several years ago the working prototypes of the device after approval of Ethical Committee was tested in about 150 patients who were ventilated with independent synchronous lung ventilation and had been found useful
The idea of the study is to check the usefulness of the device modern version in ICU patients who can be ventilated with volume -controlled mode of ventilation as an attempt to use single device for ventilation of 2 patients At this moment according to several scientific societies sharing mechanical ventilators should not be attempted because it cannot be done safely with current equipment However it is possible that using a designed flow divider will allow safe ventilation in patients without needs for complicated modes of ventilation Then maybe it will be possible to release some ventilators and to use them in patients in severe condition mainly in the era of extreme ventilator shortage In the study Ventil will ventilate one patient and instead of the second there will be an artificial lung Tidal volumes minute ventilation PEEP set and final will be checked Ppeak Pmean Pplat Cdyn airway resistance EtCO2 Sat O2 HR SAP DAP will be monitored every 2 hrs as well as blood-gas analysis every 8 hrs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None