Clinical trial NCT04475185: Safety and Effectiveness Assessment of the MakAir Artificial Ventilator
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of dysfunctions
timeFrame: 24 hours for sequence 1
measure: Number of dysfunctions
timeFrame: 5 days for sequence 2
measure: Number of dysfunctions
timeFrame: 10 days for sequence 3
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
state: Finistère
city: Nantes
country: France
facility: CHU Nantes
state: Loire-Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Antoine Roquilly, MD
role: STUDY_DIRECTOR
References: