UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041329 |
|---|---|
| Receipt number | R000046004 |
| Scientific Title | The effects of postoperative sleep disorders on the development of delirium |
| Date of disclosure of the study information | 2020/08/20 |
| Last modified on | 2022/08/09 12:45:33 |
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Basic information
Public title
The effects of postoperative sleep disorders on the development of delirium
Acronym
The effects of postoperative sleep disorders on the development of delirium
Scientific Title
The effects of postoperative sleep disorders on the development of delirium
Scientific Title:Acronym
The effects of postoperative sleep disorders on the development of delirium
Region
| Japan |
Condition
Condition
After cardiovascular surgery (coronary artery bypass grafting and/or valve surgery)
Classification by specialty
| Psychiatry | Cardiovascular surgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate sleep disorders and sleep / wake rhythm disorders in patients with post-cardiovascular surgery using a non-restrictive sleep meter to explore how they are involved in the onset of delirium.
Basic objectives2
Others
Basic objectives -Others
To evaluate sleep disorders and sleep / wake rhythm disorders in patients with post-cardiovascular surgery using a non-restrictive sleep meter to explore how they are involved in the onset of delirium.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between the incidence of delirium and sleep status
Key secondary outcomes
Sleep status (objective data by EEG measurement / matte sleep measurement, subjective data by questionnaire)
Deep body temperature rhythm analysis
Delirium severity
Delirium duration (days)
28-day non-ventilation period
ICU stay days
Outcome at discharge, 28-day mortality, 89-day mortality
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
1 Patients aged 20 years or older at the time of obtaining consent
2 Those who can speak Japanese
3 Patients who are expected to enter the ICU of the Tokyo Women's Medical University Hospital and stay for 72 hours or more
4 Patients who, after receiving a sufficient explanation for participating in this study, have a sufficient understanding and have the free written consent of the patient (or a deputy if a deputy is required)
Key exclusion criteria
History of significant CNS disease
(Stroke, head injury, CNS infection, brain tumor, after brain surgery, after cardiopulmonary resuscitation, etc.)
Patients with dementia
Alcohol and other addicts
Pregnant women or patients who may be pregnant
Other patients who the investigator determined to be inappropriate as subjects
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nomura |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Intensive Care Medicine
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
tnomura@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuo |
| Middle name | |
| Last name | Sato |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Intensive Care Medicine
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
sato.nobuo@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Hospital, Department of Intensive Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Tokyo Women's Medical University
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
Tel
03-3353-8111
ohta.megumi@twmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
5690
Org. issuing International ID_1
Ethics Committee, Tokyo Women's Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
https://twmu.bvits.com/rinri/publish.aspx
Publication of results
Unpublished
Result
URL related to results and publications
not yet
Number of participants that the trial has enrolled
20
Results
Three of the 20 patients developed delirium.
Results date posted
| 2022 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Preparing for paper submission
Date of the first journal publication of results
Baseline Characteristics
Eight patients underwent cardiac coronary artery bypass surgery and 12 underwent valve surgery.
Participant flow
The patient was admitted to the ICU after the surgery, and EEG measurement was conducted for 24 hours from 12:00 p.m. on the day following extubation.
Adverse events
None
Outcome measures
Occurrence of delirium with or without postoperative sleep disturbance
Sleep status (objective data from EEG-measured and mat-type sleep measurements, subjective data from questionnaires)
Deep body temperature rhythm analysis
Severity of delirium
Duration of delirium (days)
Non-ventilated period of 28 days
Number of days of ICU stay
28-day mortality rate, 90-day mortality rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective observational study,
From February 1, 2021, 20 patients who have undergone cardiovascular surgery at our institution and meet the selection criteria will be included in order of entry.
Management information
Registered date
| 2020 | Year | 08 | Month | 05 | Day |
Last modified on
| 2022 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046004
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| Registered date | File name |
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