Safety and Effectiveness Assessment of the MakAir Artificial Ventilator
Not Applicable
Terminated
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Device: MakAir
- Registration Number
- NCT04475185
- Lead Sponsor
- Nantes University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description MakAir MakAir -
- Primary Outcome Measures
Name Time Method Number of dysfunctions 10 days for sequence 3 Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
CHRU Brest
🇫🇷Brest, Finistère, France
CHU Nantes
🇫🇷Nantes, Loire-Atlantique, France