Acute Respiratory Distress SyndromeCOVRESPNCT04475185
Safety and Effectiveness Assessment of the MakAir Artificial Ventilator
A study testing MakAir in people with Acute Respiratory Distress Syndrome, run by Nantes University Hospital at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- MakAir
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Jul 2020to 19 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU Brest
Brest, Finistère, 29200
CHU Nantes
Nantes, Loire-Atlantique, 44000
About this study
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
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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- MakAir
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MakAirDevice
MakAir artificial ventilator
| Study group | Role | What they receive |
|---|---|---|
| MakAir | Experimental | Not described Receives: Device: MakAir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dysfunctions
Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)
Measured: 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)
Measured: 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)
Measured: 10 days for sequence 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start20 Jul 2020
- Primary completion19 Dec 2020
- Study completion19 Dec 2020
Why it 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).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Roquilly, MD, Study director, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475185
- Sponsor's protocol ID
- RC20_0173
- Acronym
- COVRESP
- Status last verified
- Dec 2021
- First submitted
- 15 Jul 2020
- Last updated
- 29 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04475185
- Acronym / sponsor ID
- COVRESP / RC20_0173
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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).
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MakAir | Experimental | Device: MakAir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MakAirMakAir artificial ventilator | Device | MakAir |
Primary outcome
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)
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)
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)
Results and safety
The study was stopped early (reason given: 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).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
Related trials for Acute Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Roquilly, MD study director
Nantes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MakAir in people with Acute Respiratory Distress Syndrome, run by Nantes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dysfunctions (time frame: 24 hours for sequence 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.