Respiratory InsufficiencyNCT04355754
Ventil Device Usefulness in Mechanically Ventilated ICU Patients
A study testing Ventil - a gas flow divider in people with Respiratory Insufficiency, run by Medical University of Gdansk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Ventil - a gas flow divider
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 15 Apr 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients who require mechanical ventilation
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdansk
Gdansk, 80-214
Magdalena A Wujtewicz, +48583493357, magwuj@gumed.edu.pl
Radoslaw Owczuk, 605408140, r.owczuk@gumed.edu.pl
About this study
Official title: Assesment of Usefulness of Ventil Device for Mechanical Ventilation in ICU Patients
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).
Read the 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)
- Conditions
- Respiratory Insufficiency
- Being tested
- Ventil - a gas flow divider
- Keywords
- critically ill patient, intensive care unit, mechanical ventilation, pandemic
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventil - a gas flow dividerDevice
Checking ventilation parameters set and obtained and clinical parameters while ventilating the patient and an artificial lung simultaneously, using inspiratory flow divider.
| Study group | Role | What they receive |
|---|---|---|
| mechanically ventilated patients | Experimental | 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 Receives: Device: Ventil - a gas flow divider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases in which it was necessary to stop using Ventil and to step- back to ventilation without this flow divider
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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start15 Apr 2020
- Primary completionMay 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Higher Education, Poland
- Responsible party
- Principal investigator, Radoslaw Owczuk, Medical University of Gdansk
- Investigators
- Radoslaw Owczuk, prof, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355754
- Sponsor's protocol ID
- Ventil-COVID-19
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Usefulness of Ventil Device for Mechanical Ventilation in ICU Patients
- ClinicalTrials.gov ID
- NCT04355754
- Acronym / sponsor ID
- Ventil-COVID-19
- Conditions
- Respiratory Insufficiency
- Keywords
- critically ill patient, intensive care unit, mechanical ventilation, pandemic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- Ministry of Science and Higher Education, Poland
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 - 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)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| mechanically ventilated patients | Experimental | Device: Ventil - a gas flow dividerAdult 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICU patients who require mechanical ventilation
Key exclusion criteria (14 listed)
- Patients who require complex modes of ventilation will not be recruited
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventil - a gas flow dividerChecking ventilation parameters set and obtained and clinical parameters while ventilating the patient and an artificial lung simultaneously, using inspiratory flow divider. | Device | mechanically ventilated patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Respiratory Insufficiency
Recruiting
Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
Nasal Airway Obstruction
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radoslaw Owczuk, prof principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventil - a gas flow divider in people with Respiratory Insufficiency, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Radoslaw Owczuk, prof (+48583493270, r.owczuk@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.