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Ventil Device Usefulness in Mechanically Ventilated ICU Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355754
Recruitment Status : Unknown
Verified April 2020 by Radoslaw Owczuk, Medical University of Gdansk.
Recruitment status was:  Recruiting
First Posted : April 21, 2020
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by (Responsible Party):
Radoslaw Owczuk, Medical University of Gdansk

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).

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: Ventil - a gas flow divider Not Applicable

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 - it's 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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The flow divider is connected to the ventilator. Half of the fresh gas flows to the patient, hallf to the artificial lung ( 1:1 ratio). For adequate ventilation tidal volume set on the ventilator is then doubled. Chosen respiratory and circulatory parameters are beeing noted.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assesment of Usefulness of Ventil Device for Mechanical Ventilation in ICU Patients
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: mechanically ventilated patients

Adult ICU patients who are mechanically ventilated and who do not require complex modes of ventilation.

A designated flow divider (Ventil) will be used to divide inspiratory gas flow from ventilator in two separate streams - one to the patient and the second to the artificial lung

Device: Ventil - a gas flow divider
Checking ventilation parameters set and obtained and clinical parameters while ventilating the patient and an artificial lung simultaneously, using inspiratory flow divider.




Primary Outcome Measures :
  1. Number of cases in which it was necessary to stop using Ventil and to step- back to ventilation without this flow divider [ Time Frame: 48 hours ]
    Ventil will be removed from the patient-ventilator circiuit in case of episodes of desaturation <90% (in pts without COPD) without reversibel reason; need for FiO2 increase by 10%; need for switch to other than CMV mode of ventillation need for neuromucular blockade or for deepen sedation because of assynchrony between patient and venilator cummulation of CO2>45 mm Hg (in pts without COPD) not responding to the increase of minute ventilation for 30 minutes; if Pplat >30 cmH2O; in case of new haemodynamic disturbances that cannot be explaned by other reasons; in case of increase or decrease of BP by 20%; increase or decrease of HR by 20%; in case of occurence of clinically important heart rhythm disturbances



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICU patients who require mechanical ventilation

Exclusion Criteria:

  • Patients who require complex modes of ventilation will not be recruited

The sudy in an individual patient be discontinued if case of:

Respiratory Criteria:

  • episodes of desaturation <90% (in pts without COPD) without reversibel reason
  • need for FiO2 increase by 10%
  • need for switch to other than CMV mode of ventillation
  • need for neuromucular blockade or for deepen sedation because of assynchrony between patient and venilator
  • cummulation of CO2>45 mm Hg (in pts without COPD) not responding to the increase of minute ventilation for 30 minutes
  • Pplat >30 cmH2O

Circulatory criteria:

  • New haemodynamic disturbances that cannot be explaned by other reasons

    • ↑ or ↓of BP by 20%
    • ↑ or ↓of HR by 20%
    • clinically important heart rhythm disturbances

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355754


Contacts
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Contact: Radoslaw Owczuk, prof +48583493270 r.owczuk@gumed.edu.pl
Contact: Magdalena A Wujtewicz, dr +48583493270 magwuj@gumed.edu.pl

Locations
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Poland
Medical University of Gdansk Recruiting
Gdansk, Poland, 80-214
Contact: Magdalena A Wujtewicz    +48583493357    magwuj@gumed.edu.pl   
Contact: Radoslaw Owczuk    605408140    r.owczuk@gumed.edu.pl   
Sponsors and Collaborators
Medical University of Gdansk
Ministry of Science and Higher Education, Poland
Investigators
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Principal Investigator: Radoslaw Owczuk, prof Medical University of Gdansk
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Responsible Party: Radoslaw Owczuk, full professor, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT04355754    
Other Study ID Numbers: Ventil-COVID-19
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radoslaw Owczuk, Medical University of Gdansk:
critically ill patient
intensive care unit
mechanical ventilation
pandemic
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases