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UMIN-CTR Clinical Trial |
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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 |
Basic information | ||
Public title | The effect of postoperative delirium on a cardiopulmonary exercise testing at dischage in aged patinets undergoing cardiac surgery
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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
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Scientific Title:Acronym | The effect of postoperative delirium on a cardiopulmonary exercise testing | |
Region |
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Condition | ||
Condition | Aged patients undergoing cardiac surgery | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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Organization | Sakurabashi-Watanabe Hospital | ||||||
Division name | Rehabilitation | ||||||
Zip code | 530-0001 | ||||||
Address | 2-4-32 Umeda Kita-ku, Osaka , Japan | ||||||
TEL | 06-6341-8651 | ||||||
fa-7y.28_5a.15@outlook.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | None |
Management information | |||||||
Registered date |
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Last modified on |
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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 |