Metran Covid-19 response project

RESUSCITATION VENTILATOR
26th AUG 2020

Metran Co.Ltd
2-12-18 Kawaguchi, Kawaguchi-shi,
Saitama-ken, 332-0015 JAPAN
TEL +81 48(242)0333 FAX +81 48(242)0550
http://www.metran.co.jp/en 1
 We thanks to sponsors and cooperator!

Van Lang University

Van Thinh Phat Group

HYPA
2
th
Van Ho, Tokyo, 26 AUG 2020
 Clinical Study
A multicenter-interventional Phase I/II study
to evaluate safety and efficacy of
Pressure-controlled ventilator (ELICIAE MV20, a product
of Metran) in patients with respiratory management

Van Ho, MD. PhD

Medical Director
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Confidential Tokyo, 26th AUG 2020 Metran-TMDU R&D Institute
 ELICIAE MV20 utilization in ICU
Study aims • Evaluate the safety and efficacy
• Simple operation

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Confidential Van Ho, Tokyo, 26th AUG 2020
Methodology
Multicenter-interventional phase I/II study

• Phase I: 10 subjects
• Evaluate operating features
• Describe any technical errors
• Evaluate user satisfaction
• System usability (SYSUSE) on PSSUQ scale
• Evaluate safety and efficacy
• Vital signs, blood gas, and clinical impacts of ventilating by MV20
• Anti-mechanical ventilation
• Compliance of ventilation
Significant change in this study were defined as changes > 10% compared to pre-study value.

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Van Ho, Tokyo, 26th AUG 2020 Confidential PSSUQ: Post Study System Usability Questionnaire
Methodology
Multicenter-interventional phase I/II study

• Phase II: 50 subjects

• Evaluate operating features
• Describe any technical errors
• Evaluate user satisfaction
• System usability (SYSUSE) on PSSUQ scale
• Evaluate safety and efficacy
• Vital signs, blood gas, and clinical impacts of ventilating by MV20
• Anti-mechanical ventilation
• Compliance of ventilation
Significant change in this study were defined as changes > 10% compared to pre-study value.

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Van Ho, Tokyo, 26th AUG 2020 Confidential PSSUQ: Post Study System Usability Questionnaire
Eligibility criteria: Inclusion
1. Adult over 18 years old
2. Subject is under pressure-controlled ventilation via endotracheal tube with two
modes as following:
§ Pressure controlled mechanical ventilator (PCMV)
§ Pressure support/ control mechanical ventilator (PS/AMV)
3. The cause of pressure-controlled ventilating in subject did not associate to
respiratory disorder.
4. Subjects are under 24h stable with pressure-controlled ventilating (adjust by two
blood gases, the last one within 6 hours before starting MV20)
5. Guardian approves the interventional study with signatures

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Confidential
Van Ho, Tokyo,
26thAUG 2020 Van Ho, Tokyo, 26th AUG 2020
Eligibility criteria: Exclusion
1. Patients with external oxygen exchanger such as ECMO
2. Patients are in life-threatening within 24hs
3. Patients are in progress of A-B balancing by bicarbonate infusion
4. Patients are pregnancy
5. Guardian does not follow procedure of this study
6. Exclusion due to discretion of PI

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Confidential Van Ho, Tokyo, 26th AUG 2020
 Study schema

Ø Pressure-controlled
ventilation
Ø Pressure-support/assist
Ventilation

Ø Pressure-controlled
ventilation
Ø Pressure-support/assist
Ventilation
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Confidential Van Ho, Tokyo, 26th AUG 2020
 Study schedule
Follow-
Screening Treatment
up*
Schedule -24h -6h 0h 15m 30m 45m 1h 1h15m 1h30m 1h45m 2h 3h 6h
Visit 1 2 3 4 5 6 7 8 9 10 11 12 13
Spontaneously PCV/PSV X X
Inform consent X
Eligibly criteria X
Setting up MV20 X*
MV20 start-ventilating X
MV20 end-ventilating X
Demographic X
Medical history X
Physical examination X X X X X X X X X X X X X
Vital signs X X X X X X X X X X X X X
Arterial blood gas X X** X X X X
FiO2 X X X X X X X X X X
SPO2 X X X X X X X X X X X X
Vte X X X X X X X X X X
PIP and PEEP X X X X X X X X X X
Adverse events X X X X X X X X X X X X
Adjust ventilatory
X X X X X X X X X
setting
Operating survey X X
Complication of MV20 X X X X X X X X X 10
Milestone

Duration of Screening period: 24 hours

study Treatment period: 2 hours
Follow up period: 6 hours (in case of AE)
Timeline EC protocol approval: 8JUN2020
First patient in: 9JUN2020 (Phase I LPO: 15JUN2020)
Last patient out phase II: 10JUL2020
Phase I clinical study report: 17JUN2020 (10 subjects)
Phase II clinical study report: 12JUL2020 (51 subjects)
EC defense meeting: 13JUL2020
CFS approval: 30JUL2020
--> ELICIAE MV20 has approved to treat Covid-19 patients.
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Confidential Van Ho, Tokyo, 26th AUG 2020
Project coordinators:

• Bach Mai Hospital

• Do Ngoc Son, MD. PhD
• Dao Xuan Co, Asc. Professor. MD. PhD
• Cho Ray Hospital
• Truong Duong Tien, MD. PhD
• Metran
• Representative: Kazufuku Nitta (Tran Ngoc Phuc)
• Medical director: Ho Van, MD. PhD

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Confidential Van Ho, Tokyo, 26th AUG 2020
 Study results

Number of subjects: 61
Period of ventilation: 122 hours

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Van Ho, Tokyo, 26th AUG 2020 Confidential * Data are not represented all subjects.
At sites…
MV20 and monitor

Metran
MV20

Monitoring
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Confidential Van Ho, Tokyo, 26th AUG 2020
 Subject background
Included:
- Head trauma
- Intracranial hemorrhage
- Muscular dysfunction
- Sepsis with source other than pneumonia
- Suicide by robe
- Acute pneumonia post operation

Confidential Van Ho, Tokyo, 26th AUG 2020

 Demographic
Male (n,%): 33 (65)
Distribution of Age
40 Mean 52.4
Std Devi ati on 18.64403
Mi ni mum 22
PHASE = Phase 1 30 Maxi mum
N
75
10

20

10
Percent

0
40 Mean 56.68627
Std Devi ati on 16.66192
Mi ni mum 17
PHASE = Phase 2

30 Maxi mum 84
N 51

20

10

0
-30 -15 0 15 30 45 60 75 90 105 120
A ge
Curves Normal Kernel(c=0.79)

Age of study population is mainly between 45 – 75 year old.

Confidential Van Ho, Tokyo, 26th AUG 2020
 Ventilation mode

41%
59% PMCV
PS/AMV

Confidential Van Ho, Tokyo, 26th AUG 2020

 Post Study System Usability Questionnaire (PSSUQ Score)

Description Score

SYSUSE System Usefulness 3.3

INFOQUAL Information Quality 3.7

INTERQUAL Interface Quality 3.8

OVERALL 3.6

ELICIAE MV20 is able to operate in simple way.

Score is from 1 ～ 7, strong agree ～ disagree

Confidential Van Ho, Tokyo, 26th AUG 2020

 Technical errors
Items Frequency (n,%)
Technical errors due to
0 (0)
Phase I operators
(10 subjects) Technical errors due to
0 (0)
ELICIAE MV20
Technical errors due to
0 (0)
Phase II operators
(51 subjects) Technical errors due to
0 (0)
ELICIAE MV20
ELICIAE MV20 is able to operate in simple way.

Confidential Van Ho, Tokyo, 26th AUG 2020

 Vital signs – Heart rate
(BPM) Heart rate (bpm)

Base- T15 T30 T45 T60 T75 T90 T105 T120

line
Monitoring time

Heart rate of subjects mostly stables around 100 beats per minute.
Confidential Van Ho, Tokyo, 26th AUG 2020
 Vital signs – Blood pressure
SBP and DBP

Base- T15 T30 T45 T60 T75 T90 T105 T120

line
Monitoring time
DBP (mmHg) SBP (mmHg)

Blood pressure of subjects mostly was stable during

hour of MV20 ventilating.
Confidential Van Ho, Tokyo, 26th AUG 2020
 SPO2
SPO2 (%)

Base- T15 T30 T45 T60 T75 T90 T105 T120

line
Monitoring time

SPO2 of subjects was over 96%

Confidential Van Ho, Tokyo, 26th AUG 2020
 PH

Time (mins) Mean SD Min Max Median

T0 7.47 0.06 7.36 7.54 7.49

T60 7.42 0.08 7.31 7.52 7.45

T120 7.39 0.09 7.20 7.48 7.40

Acid – base is balance during hour of MV20 ventilating.

Confidential Van Ho, Tokyo, 26th AUG 2020

 PCO2
PCO2 (mmHg)
80
60
40
20
0
T0 T60 T120
P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 P11 P12 P13 P14 P15
P16 P17 P18 P19 P20 P21 P22 P23 P24 P25 P26 P27 P28 P29 P30
P31 P32 P33 P34 P35 P36 P37 P38 P39 P40 P41 P42 P43 P44 P45
P46 P47 P48 P49 P50 P51 P52 P53 P54 P55 P56 P57

CO2 likely stables during hour of MV20 ventilating.

Confidential Van Ho, Tokyo, 26th AUG 2020

 PO2

Mean
Time (mins) SD Min Max Midian
(mmHg)
107.78 36.85 66.90 190.10 105.00
T0

T60 125.02 33.35 88.00 203.40 120.50

130.72 25.74 94.40 176.90 136.00

T120

O2 keeps stable in bio-normal range during hour of MV20 ventilating.

Confidential Van Ho, Tokyo, 26th AUG 2020
 HCO3
Distribution of HCO3
35

30

HCO3 25

20

F 0.10
Prob > F 0.9019

T0
1 T60
2 T120
3
VISITNUM

HCO3- keeps stable in normal range during hour of MV20 ventilating.

Confidential Van Ho, Tokyo, 26th AUG 2020

 LACTATE
Distribution of Lactac
F 0.08
Prob > F 0.9191
5

Lactac
3

T0
1
T60
2
T120
3

VISITNUM

Lactate keeps stable in bio-normal range during hour of MV20 ventilating.

Confidential Van Ho, Tokyo, 26th AUG 2020

 Conclusion
ØELICIAE MV20 performance in critical patients has similar

operation in comparison to high-end ventilator

ØELICIAE MV20 has approved to use for treating Covid-19

patients and long-term use after covid-19 pandemic

ØCFS approval on 30Jul2020

Confidential Van Ho, Tokyo, 26th AUG 2020

Contact information:

Ho Van, MD. PhD

Medical Direcor,
Metran – TMDU R&D Institute
22F/M&D Tower, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510
Tel: +81-90-1335-2388 Fax: +81-48-242-0550
HP: http://www.metran.co.jp/en/

Email: hovan@metran.co.jp

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