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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04475185
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Device: MakAir Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : July 20, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: MakAir Device: MakAir
MakAir artificial ventilator




Primary Outcome Measures :
  1. Number of dysfunctions [ Time Frame: 24 hours for sequence 1 ]
    Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)

  2. Number of dysfunctions [ Time Frame: 5 days for sequence 2 ]
    Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)

  3. Number of dysfunctions [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475185


Contacts
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Contact: Antoine Roquilly, MD 253482230 ext +33 Antoine.ROQUILLY@chu-nantes.fr

Locations
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France
CHRU Brest Recruiting
Brest, Finistère, France, 29200
Contact: Erwan L'Her, MD       erwan.lher@chu-brest.fr   
CHU Nantes Recruiting
Nantes, Loire-Atlantique, France, 44000
Contact: Antoine Roquilly, MD    (+33)253482230    antoine.roquilly@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Study Director: Antoine Roquilly, MD CHU Nantes
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04475185    
Other Study ID Numbers: RC20_0173
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury