Safety and Effectiveness Assessment of the MakAir Artificial Ventilator

  • STATUS
    Recruiting
  • participants needed
    117
  • sponsor
    Nantes University Hospital
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Updated on 16 February 2024
See if I qualify
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 18years - 100years
Treatment MakAir
Clinical Study IdentifierNCT04475185
SponsorNantes University Hospital
Last Modified on16 February 2024

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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