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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016616
Receipt No. R000019267
Scientific Title Acid-base Balance & Oxygen management in patients required mechanical Ventilation - Evaluation study=
Date of disclosure of the study information 2015/02/27
Last modified on 2019/06/09

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Basic information
Public title Acid-base Balance & Oxygen management
in patients required mechanical Ventilation - Evaluation study=

Acronym ABOVE study
Scientific Title Acid-base Balance & Oxygen management
in patients required mechanical Ventilation - Evaluation study=

Scientific Title:Acronym ABOVE study
Region
Japan

Condition
Condition Critically ill patients required mechanical ventilation for more than 48 hours
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To observe how often hyperoxia and Hypoxia occurred.

2) To observe how physicians react for hyperoxia and hypoxia. (change PEEP and/or FIO2)?

3) How PEEP and FIO2 are combined?

4) To assess the association of maximum (hyper), minimum (hypo) and time weighted average of SpO2 with clinical outcomes (28 days mortality, Ventilator free days at 28 day, intensive care free days at 28 days)

5) To assess the association with the reaction of physicians to hyperoxia with clinical outcomes.

6) To observe mode, PEEP, end inspiratory plateau pressure, tidal volume and Acid base-balance including pH, PaCO2 and B.E.

7) To observe the incidence of alkaremia and acidemia in mechanical ventilation patients and assess its impact on clinical outcomes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 28 days mortality
Key secondary outcomes ICU free survival days within 28 days after admission in ICU
Mechanical ventilation free survival days within 28 days after admission in ICU

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Critically ill patients required mechanical ventilation for more than 48 hours
Key exclusion criteria Pateints who considered at risk for imminent death.
Patients who required extra-corporeal membrane oxygenation (ECMO).
Patients who ask us not use their clinical infmroation.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Moritoki
Middle name
Last name Egi
Organization Kobe University Hospital
Division name Department of anesthesiology
Zip code 6500017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN, 650-0017
TEL 078-382-6172
Email moriori@tg8.so-net.ne.jp

Public contact
Name of contact person
1st name Moritoki
Middle name
Last name Egi
Organization Kobe University Hospital
Division name Department of anesthesiology
Zip code 6500017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN, 650-0017
TEL 078-382-6172
Homepage URL
Email moriori@tg8.so-net.ne.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

Funding Source
Organization Kobe University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB comittee Kobe University hospital
Address 7-5-2 Kusunoki tyo, Kobe city, Hyogo
Tel 078-382-5111
Email moriori@tg8.so-net.ne.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 27 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 Completed
Date of protocol fixation
2014 Year 10 Month 09 Day
Date of IRB
2014 Year 10 Month 24 Day
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
2015 Year 05 Month 31 Day
Date of closure to data entry
2017 Year 02 Month 25 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information 1) Patients demographics
We will collect information on age, sex, heights, weights, the day for ICU admission, the day for start MV, reasons for ICU admission (surgical and non-surgical, infection or non-infection, trauma or non-trauma) and Acute Physiology and Chronic Health Evaluation (APACHE) II score. We will also collect the reason for requirement of mechanical ventilation.

2) Oxygen administration and the staement of mechanical ventilation
3times per day(6:00-10:00, 14:00-18:00, 22:00-2:00) as much as patients were stable condition.
MODE of mechanical ventilation, PEEP level, Peak pressure, minute volume, respiratory rate, FIO2, SpO2

3) Arterial blood gas information
3times per day(6:00-10:00, 14:00-18:00, 22:00-2:00) as much as patients were stable condition.PH, PaCO2, PaO2, HCO3, B.E., Hb, SaO2, Na+, K+, Cl-, Ca++, Lactate

4) Albumin levels (daily)

5) Outcome
The status (dead or alive) at 28 days after admission in ICU.
The day for commence and decease of mechanical ventilation.
The day of ICU admission and discharge
The day of hospital admission and discharge
The day for requirement of renal replacement therapy

Management information
Registered date
2015 Year 02 Month 24 Day
Last modified on
2019 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019267

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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