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COVRESP: Safety and Effectiveness Assessment of the MakAir Artificial Ventilator

Sponsor
Nantes University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT04475185
Collaborator
(none)
4
Enrollment
2
Locations
1
Arm
5
Actual Duration (Months)
2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MakAir
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
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 :
Jul 20, 2020
Actual Primary Completion Date :
Dec 19, 2020
Actual Study Completion Date :
Dec 19, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: MakAir

Device: MakAir
MakAir artificial ventilator

Outcome Measures

Primary Outcome Measures

  1. Number of dysfunctions [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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>

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU Brest Brest Finistère France 29200
2 CHU Nantes Nantes Loire-Atlantique France 44000

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

  • Study Director: Antoine Roquilly, MD, CHU Nantes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT04475185
Other Study ID Numbers:
  • RC20_0173
First Posted:
Jul 17, 2020
Last Update Posted:
Dec 29, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury

Study Results

No Results Posted as of Dec 29, 2021