Ventil Device Usefulness in Mechanically Ventilated ICU Patients

NCT04355754 | Unknown

• 1 other identifier: Ventil-COVID-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Insufficiency

Keywords

critically ill patient; intensive care unit; mechanical ventilation; pandemic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Device: Ventil - a gas flow divider

Interventions

Ventil - a gas flow divider DEVICE

Checking ventilation parameters set and obtained and clinical parameters while ventilating the patient and an artificial lung simultaneously, using inspiratory flow divider.

mechanically ventilated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICU patients who require mechanical ventilation

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead
• Ministry of Science and Higher Education, Poland: collaborator

Study Sites (1)

Medical University of Gdansk

Gdansk, 80-214, Poland

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Radoslaw Owczuk, prof

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radoslaw Owczuk, prof

CONTACT

+48583493270; r.owczuk@gumed.edu.pl

Magdalena A Wujtewicz, dr

CONTACT

+48583493270; magwuj@gumed.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full professor

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 21, 2020
• Study Start: April 15, 2020
• Primary Completion: May 1, 2020
• Study Completion: December 31, 2020
• Last Updated: April 27, 2020

Record last verified: 2020-04

Locations

PL (1)