Safety and Effectiveness Assessment of the MakAir Artificial Ventilator

Acute Respiratory Distress Syndrome Clinical Trial

— COVRESP  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04475185
• Other study ID #: RC20_0173
• Status: Terminated
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: December 19, 2020

Study information

• Verified date: December 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 19, 2020
• Est. primary completion date: December 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• MakAir
MakAir artificial ventilator

Locations

Country	Name	City	State
France	CHRU Brest	Brest	Finistère
France	CHU Nantes	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of dysfunctions	Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)	24 hours for sequence 1
Primary	Number of dysfunctions	Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)	5 days for sequence 2
Primary	Number of dysfunctions	Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)	10 days for sequence 3