Ventil Device Usefulness in Mechanically Ventilated ICU Patients

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).

Study Overview

• Status: Unknown
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: Device: Ventil - a gas flow divider

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdansk, Poland, 80-214
    • Recruiting
    • Medical University of Gdansk
    • Contact: Magdalena A Wujtewicz; Phone Number: +48583493357; Email: magwuj@gumed.edu.pl
    • Contact: Radoslaw Owczuk; Phone Number: 605408140; Email: r.owczuk@gumed.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 hours

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Collaborators: Ministry of Science and Higher Education, Poland
• Investigators: Principal Investigator: Radoslaw Owczuk, prof, Medical University of Gdansk

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 18, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: intensive care unit; mechanical ventilation; pandemic; critically ill patient
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: Ventil-COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No