Safety and Effectiveness Assessment of the MakAir Artificial Ventilator

NCT04475185 | Terminated

• 1 other identifier: RC20_0173
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

MakAir

EXPERIMENTAL

Device: MakAir

Interventions

MakAir DEVICE

MakAir artificial ventilator

MakAir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

CHRU Brest

Brest, Finistère, 29200, France

Location

CHU Nantes

Nantes, Loire-Atlantique, 44000, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Antoine Roquilly, MD

  Nantes University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 17, 2020
• Study Start: July 20, 2020
• Primary Completion: December 19, 2020
• Study Completion: December 19, 2020
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

FR (2)