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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MakAir
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU Brest
  • CHU Nantes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MakAir

Arm Description

Outcomes

Primary Outcome Measures

Number of dysfunctions
Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)
Number of dysfunctions
Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)
Number of dysfunctions
Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)

Secondary Outcome Measures

Full Information

First Posted
July 15, 2020
Last Updated
December 8, 2021
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04475185
Brief Title
Safety and Effectiveness Assessment of the MakAir Artificial Ventilator
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Manufacturer's decision following failure of sequence 2. Protocol unadapted to the security and performance evaluation of the new MakAir device capabilities in non-invasive ventilation (NIV).
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
December 19, 2020 (Actual)
Study Completion Date
December 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MakAir
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MakAir
Intervention Description
MakAir artificial ventilator
Primary Outcome Measure Information:
Title
Number of dysfunctions
Description
Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)
Time Frame
24 hours for sequence 1
Title
Number of dysfunctions
Description
Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)
Time Frame
5 days for sequence 2
Title
Number of dysfunctions
Description
Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)
Time Frame
10 days for sequence 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Roquilly, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
CHRU Brest
City
Brest
State/Province
Finistère
ZIP/Postal Code
29200
Country
France
Facility Name
CHU Nantes
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

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Safety and Effectiveness Assessment of the MakAir Artificial Ventilator

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