Safety and Effectiveness Assessment of the MakAir Artificial Ventilator

STATUS

Recruiting
participants needed

117
sponsor

Nantes University Hospital

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Updated on 19 February 2024

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mechanical ventilation

pao2

FIO2

respiratory distress

covid-19

acute respiratory distress

fraction of inspired oxygen (fio2)

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.

Details

Condition	Pulmonary Disease, ADULT RESPIRATORY DISTRESS SYNDROME
Age	18-100 years
Treatment	MakAir
Clinical Study Identifier	NCT04475185
Sponsor	Nantes University Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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Safety and Effectiveness Assessment of the MakAir Artificial Ventilator