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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047693
Receipt No. R000045410
Scientific Title The effect of postoperative delirium on a cardiopulmonary exercise testing at dischage in aged patinets undergoing cardiac surgery
Date of disclosure of the study information 2022/05/09
Last modified on 2022/05/09

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Basic information
Public title The effect of postoperative delirium on a cardiopulmonary exercise testing at dischage in aged patinets undergoing cardiac surgery
Acronym The effect of postoperative delirium on a cardiopulmonary exercise testing
Scientific Title The effect of postoperative delirium on a cardiopulmonary exercise testing at dischage in aged patinets undergoing cardiac surgery
Scientific Title:Acronym The effect of postoperative delirium on a cardiopulmonary exercise testing
Region
Japan

Condition
Condition Aged patients undergoing cardiac surgery
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect of delirium on cardiopulmonary exercise testing at discharge
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AT-VO2 VE/VCO2 slope
Key secondary outcomes

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
70 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria cardiac surgical patients
Key exclusion criteria patients who did not dischage
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Yuta
Middle name
Last name Shimomoto
Organization Sakurabashi-Watanabe Hospital
Division name Rehabilitation
Zip code 530-0001
Address 2-4-32 Umeda Kita-ku, Osaka , Japan
TEL 06-6341-8651
Email fa-7y.28_5a.15@outlook.jp

Public contact
Name of contact person
1st name Yukio
Middle name
Last name Hayashi
Organization Sakurabashi-Watanabe Hospital
Division name Anesthesiology
Zip code 530-0001
Address 2-4-32 Umeda Kita-ku Osaka, Japan
TEL 06-6341-8651
Homepage URL
Email yhayashi@anes.med.osaka-u.ac.jp

Sponsor
Institute Sakurabashi-Watanabe Hospital
Institute
Department

Funding Source
Organization Sakurabashi-Watanabe Hospital
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 Sakurabashi-Watanabe Hospital IRB
Address 2-4-32 Umeda Kita-ku Osaka, Japan
Tel 06-6341-8651
Email i_oka@watanabe-hsp.or.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
2022 Year 05 Month 09 Day

Related information
URL releasing protocol http://www.watanabe-hsp.or.jp/hospitalinfo/optout
Publication of results Unpublished

Result
URL related to results and publications https://www.meeting-schedule.com/jsicm47/author.html
Number of participants that the trial has enrolled 70
Results AT-VO2 and the slope of VCO2 and VE in the presence and absence of delirium and both values were comparable between the groups.
Results date posted
2022 Year 05 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Seventy patients aged 70 or older undergoing cardiac valve surgery, entered our ICU and were discharged from our hospital between June 2016 and July 2018.
Participant flow All patients received active exercise from our rehabilitation team since the first postoperative day while on mechanical ventilation, and performed a CPX on a cycle ergometer before discharge.
Adverse events No problem
Outcome measures AT-VO2 VE/VCO2slope
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
2019 Year 08 Month 01 Day
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2022 Year 05 Month 09 Day
Last modified on
2022 Year 05 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045410

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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