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Safety and Effectiveness Assessment of the MakAir Artificial Ventilator

NCT ID: NCT04475185

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2020-12-19

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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MakAir

Group Type EXPERIMENTAL

MakAir

Intervention Type DEVICE

MakAir artificial ventilator

Interventions

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MakAir

MakAir artificial ventilator

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine Roquilly, MD

Role: STUDY_DIRECTOR

Nantes University Hospital

Locations

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CHRU Brest

Brest, Finistère, France

Site Status

CHU Nantes

Nantes, Loire-Atlantique, France

Site Status

Countries

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France

Other Identifiers

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RC20_0173

Identifier Type: -

Identifier Source: org_study_id