Interventional, Open, Non-comparative, Multicenter Study to Assess the Safety and Effectiveness of the Use of the MakAir Artificial Ventilator in the Expected Situation of a Shortage of Technical Devices for Invasive Mechanical Ventilation, Linked to the Coronavirus COVID-19

Nantes University Hospital2 sites in 1 country4 target enrollmentJuly 20, 2020

ConditionsAcute Respiratory Distress Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Respiratory Distress Syndrome
Sponsor: Nantes University Hospital
Enrollment: 4
Locations: 2
Primary Endpoint: Number of dysfunctions
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of our study is to carry out an evaluation of the safety and the effectiveness of the use of the MakAir respirator as useful supplement in situation of shortage of technical devices of assistance to the mechanical invasive ventilation, related to COVID-19 through a protocol in 3 successive sequences.

Registry

clinicaltrials.gov

Start Date

July 20, 2020

End Date

December 19, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Sequence 1 :
•Patient for whom a certificate has been signed by a support person / family member / close relative independent of the sponsor.
•Non-hypoxemic patient (PaO2 / FiO2\> 300)
•Patient requiring invasive mechanical ventilation\> 24 hours
•Stabilized patient, i.e. not needing an increase in oxygenation for at least 6 hours
•Sequence 2 :
•Patient for whom a certificate of consent has been signed by a support person / family member / close relative independent of the sponsor.
•Patient with mild to moderate Acute respiratory distress syndrome (300\> Pa02 / FiO2\> 100)
•Patient requiring invasive mechanical ventilation\> 3 days
•Stabilized patient, i.e. having not required an increase in oxygenation for at least 6 hours

Exclusion Criteria

•Sequence 1 and sequence 2:
•Patient positive or showing signs of Covid-19 infection
•Tracheotomized patient
•History of pulmonary emphysema or severe to moderate chronic obstructive pulmonary disease
•Patient in recovery and withdrawal phase of ventilatory assistance
•Pneumothorax or pneumomediastinum
•Hemodynamic instability
•Intracranial hypertension
•Pregnant woman (A urine or blood pregnancy test must be performed for women of childbearing age)
•Major protected (guardianship, curatorship and under the protection of justice)