Safety and Effectiveness Assessment of the MakAir Artificial Ventilator (COVRESP)

Nantes University Hospital (NUH)

Status

Terminated

Conditions

Acute Respiratory Distress Syndrome

Treatments

Device: MakAir

Study type

Interventional

Funder types

Other

Identifiers

NCT04475185

RC20_0173

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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