Unique ID issued by UMIN | UMIN000042551 |
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Receipt number | R000048567 |
Scientific Title | The Mega Randomised Registry Trial Comparing Conservative vs. Liberal OXygenation Targets |
Date of disclosure of the study information | 2020/11/25 |
Last modified on | 2022/11/27 09:49:22 |
The Mega Randomised Registry Trial Comparing Conservative vs. Liberal OXygenation Targets
Mega-ROX
The Mega Randomised Registry Trial Comparing Conservative vs. Liberal OXygenation Targets
Mega-ROX
Japan | Asia(except Japan) | North America |
South America | Australia | Europe |
Mechanical ventilation
Intensive care medicine |
Others
NO
Obtaining definitive evidence regarding the mortality risk associated with conservative oxygen therapy vs. liberal oxygen therapy in mechanically ventilated ICU patients
Efficacy
in-hospital all-cause mortality up to 90 days from the date of randomisation
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Maneuver |
FIO2 will be decreased to 0.21 (room air) as rapidly as possible provided that the SpO2 measured by peripheral pulse oximetry is greater than the acceptable lower limit.
No specific measures will be taken to avoid high FIO2 or high SpO2 (including no upper alarm limit for SpO2).
18 | years-old | <= |
Not applicable |
Male and Female
Patients =>18 years who require invasive mechanical ventilation in the ICU following an emergency (unplanned) ICU admission OR those starting mechanical ventilation in the ICU (i.e. intubated in the ICU) will be eligible for inclusion.
Enrolment is not considered in a particular patient's best interests by the treating clinician.
Previously enrolled in Mega-ROX.
40000
1st name | Tomoko |
Middle name | |
Last name | Fujii |
Jikei University
Intensive Care Unit, Department of Anesthesiology
105-8471
3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo
03-3433-1111
tofujii-tky@umin.net
1st name | Tomoko |
Middle name | |
Last name | Fujii |
Jikei University
Intensive Care Unit, Department of Anesthesiology
105-8471
3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo
03-3433-1111
tofujii-tky@umin.net
Jikei University
Medical Research Institute of New Zealand
Outside Japan
Global Sponsor: Medical Research Institute of New Zealand
The Ethics Committee of the Jikei University School of Medicine for Biomedical Research
3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo
03-3433-1111
rinri@jikei.ac.jp
YES
ACTRN12620000391976
the Australian and New Zealand Clinical Trials Registry
東京慈恵会医科大学附属病院(東京都)、関西医科大学附属病院(大阪府)、和歌山県立医科大学救命救急センター(和歌山県)、福山市民病院(広島県)、横浜市立大学附属病院(神奈川県)、名古屋大学医学部附属病院(愛知県)
2020 | Year | 11 | Month | 25 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 06 | Month | 10 | Day |
2020 | Year | 09 | Month | 07 | Day |
2020 | Year | 12 | Month | 07 | Day |
2025 | Year | 11 | Month | 30 | Day |
2020 | Year | 11 | Month | 25 | Day |
2022 | Year | 11 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048567
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