Safety and Effectiveness Assessment of the MakAir Artificial Ventilator

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: MakAir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sequence 1 : Patient for whom a certificate has been signed by a support person / family member / close relative independent of the sponsor. Adult 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. Adult 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 Sequence3 : Patient for whom a certificate of consent has been signed by a support person / family member / close relative independent of the sponsor or waiver due to life-threatening emergency. Adult Patient with mild to moderate Acute respiratory distress syndrome (PaO2 / FiO2> 100) or without Acute respiratory distress syndrome Patient requiring invasive mechanical ventilation for any duration Situation of shortage among centers investigating technical devices for invasive ventilation to treat all patients 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) Lack of affiliation to the French social security system Participation in another interventional clinical trial Sequence3 : Tracheotomized patient History of pulmonary emphysema or severe to moderate 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) Lack of affiliation to the French social security system Participation in another interventional clinical trial on mechanical ventilation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MakAir<br> | Device: MakAir<br>* MakAir artificial ventilator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of dysfunctions | Number of dysfunctions which can lead to or have led to respiratory adverse events or to serious adverse events (SAE) | 24 hours for sequence 1 | 
| Number of dysfunctions | Number of dysfunctions which can lead to or have led to respiratory adverse events or to serious adverse events (SAE) | 5 days for sequence 2 | 
| Number of dysfunctions | Number of dysfunctions which can lead to or have led to respiratory adverse events or to serious adverse events (SAE) | 10 days for sequence 3 |