Status:
TERMINATED
Safety and Effectiveness Assessment of the MakAir Artificial Ventilator
Lead Sponsor:
Nantes University Hospital
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04475185
Start Date
July 20 2020
End Date
December 19 2020
Last Update
December 29 2021
Active Locations (2)
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1
CHRU Brest
Brest, Finistère, France, 29200
2
CHU Nantes
Nantes, Loire-Atlantique, France, 44000