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.
Device: MakAir
MakAir artificial ventilator
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
CHRU Brest
Brest, Finistère, France
CHU Nantes
Nantes, Loire-Atlantique, France
Antoine Roquilly, MD, Study Director
CHU Nantes