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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000030918
Receipt No. R000035305
Scientific Title Effect of remote ischemic preconditioning in improving postoperative pulmonary function in adult patients: A meta-analysis with trial sequential analysis
Date of disclosure of the study information 2018/08/01
Last modified on 2019/07/24

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Basic information
Public title Effect of remote ischemic preconditioning in improving postoperative pulmonary function in adult patients: A meta-analysis with trial sequential analysis
Acronym Effect of remote ischemic preconditioning on postoperative pulmonary function
Scientific Title Effect of remote ischemic preconditioning in improving postoperative pulmonary function in adult patients: A meta-analysis with trial sequential analysis
Scientific Title:Acronym Effect of remote ischemic preconditioning on postoperative pulmonary function
Region
Japan

Condition
Condition Patients who undergo general anesthesia
Classification by specialty
Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of remote ischemic preconditioning on postoperative pulmonary function was controversial. The aim of this study is to investigate the effect of remote ischemic preconditioning on postoperative pulmonary function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome of the present meta-analysis is the PaO2/FIO2 ratio 24 hours after surgery.
Key secondary outcomes The secondary outcomes are the incidence of pulmonary complication, postoperative inflammation, acute kidney injury, cardiac function.

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We search for all randomized controlled trials that tested the effect of remote ischemic preconditioning on postoperative pulmonary function.
Key exclusion criteria We exclude data case reports, comments or letters to the editor, reviews, and animal studies. Eligibility is not restricted by language, type of surgery, anesthetic technique, or patient age.
Target sample size 0

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Mihara
Organization Yokohama City University Hospital
Division name Department of Anesthesiology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama city
TEL 045-787-2800
Email miharaxxxtotoro@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Mihara
Organization Yokohama City University Hospital
Division name Department of Anesthesiology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama city
TEL 0457872800
Homepage URL
Email miharaxxxtotoro@yahoo.co.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 08 Month 01 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 Suspended
Date of protocol fixation
2018 Year 01 Month 21 Day
Date of IRB
1977 Year 01 Month 01 Day
Anticipated trial start date
2018 Year 01 Month 31 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study protocol is attached in this pre-registration or can be seen at http://www-user.yokohama-cu.ac.jp/~masuika/protocol/
MEDLINE, CENTRAL, Embase, and Web of Science are searched. Further, we conduct a search of clinicaltrials.gov and the UMIN Clinical Trials Registry.
Two authors independently scan the titles and abstracts of reports identified by the variety of search strategies described above. The articles that meet the inclusion criteria are assessed separately by two authors, and any discrepancies are resolved through discussion.
Continuous data are summarized using mean difference with a 95% confidence interval. Dichotomous data are summarized using risk ratio with a 95% CI. Heterogeneity is quantified with the I2 statistic. We consider that significant heterogeneity existed when the I2 statistic exceeded 50%. We plan to conduct subgroup analysis according to the following predefined factors when the I2 statistic exceeded 50%: type of anesthesia, type of surgery, or patients age. We use the random effect model to combine the results. For our primary outcome, trial sequential analysis are performed to correct for random error and repetitive testing of accumulating and sparse data. Risk of type 1 error is maintained at 5% with a power of 90%. The mean difference of the PaO2/FIO2 ratio 24 hours after surgery of 50 was considered clinically meaningful.

Management information
Registered date
2018 Year 01 Month 21 Day
Last modified on
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035305

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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