UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042551
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

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Basic information

Public title

The Mega Randomised Registry Trial Comparing Conservative vs. Liberal OXygenation Targets

Acronym

Mega-ROX

Scientific Title

The Mega Randomised Registry Trial Comparing Conservative vs. Liberal OXygenation Targets

Scientific Title:Acronym

Mega-ROX

Region

Japan Asia(except Japan) North America
South America Australia Europe


Condition

Condition

Mechanical ventilation

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Obtaining definitive evidence regarding the mortality risk associated with conservative oxygen therapy vs. liberal oxygen therapy in mechanically ventilated ICU patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

in-hospital all-cause mortality up to 90 days from the date of randomisation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

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.

Interventions/Control_2

No specific measures will be taken to avoid high FIO2 or high SpO2 (including no upper alarm limit for SpO2).

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion criteria

Enrolment is not considered in a particular patient's best interests by the treating clinician.

Previously enrolled in Mega-ROX.

Target sample size

40000


Research contact person

Name of lead principal investigator

1st name Tomoko
Middle name
Last name Fujii

Organization

Jikei University

Division name

Intensive Care Unit, Department of Anesthesiology

Zip code

105-8471

Address

3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Email

tofujii-tky@umin.net


Public contact

Name of contact person

1st name Tomoko
Middle name
Last name Fujii

Organization

Jikei University

Division name

Intensive Care Unit, Department of Anesthesiology

Zip code

105-8471

Address

3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Homepage URL


Email

tofujii-tky@umin.net


Sponsor or person

Institute

Jikei University

Institute

Department

Personal name



Funding Source

Organization

Medical Research Institute of New Zealand

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization



Other related organizations

Co-sponsor

Global Sponsor: Medical Research Institute of New Zealand

Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethics Committee of the Jikei University School of Medicine for Biomedical Research

Address

3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo

Tel

03-3433-1111

Email

rinri@jikei.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

ACTRN12620000391976

Org. issuing International ID_1

the Australian and New Zealand Clinical Trials Registry

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

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)


Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2020 Year 06 Month 10 Day

Date of IRB

2020 Year 09 Month 07 Day

Anticipated trial start date

2020 Year 12 Month 07 Day

Last follow-up date

2025 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 25 Day

Last modified on

2022 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048567


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name