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

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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: MakAir

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Finistère
    • Brest, Finistère, France, 29200
      • CHRU Brest
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44000
      • CHU Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MakAir	Device: MakAir; MakAir artificial ventilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Study Director: Antoine Roquilly, MD, CHU Nantes

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2020
• Primary Completion (ACTUAL): December 19, 2020
• Study Completion (ACTUAL): December 19, 2020

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (ACTUAL): July 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: RC20_0173

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No