Unique ID issued by UMIN | UMIN000041236 |
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Receipt number | R000045873 |
Scientific Title | Association between Delirium and GRip Strength in ICU Patients for Cardiac Surgery |
Date of disclosure of the study information | 2020/08/01 |
Last modified on | 2023/10/26 07:12:02 |
Association between Delirium and GRip Strength in ICU Patients for Cardiac Surgery
D-GRIP Study
Association between Delirium and GRip Strength in ICU Patients for Cardiac Surgery
D-GRIP Study
Japan |
Cardiac surgery
Anesthesiology |
Others
NO
The purpose of this study is to investigate whether improving grip strength with short-term grip training before cardiac surgery suppresses postoperative delirium.
Efficacy
Incidence of delirium during admission to the intensive care unit
1) Delirium incidence after POD 2
2) Number of days ICU stays
3) Mortality after 30 days
4) Change rate of WHODAS 2.0
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Placebo
2
Treatment
Device,equipment |
Intervention group
At the time of the first visit to the outpatient clinic, the left and right grip strength is measured, and a hand gripper with 50% of grip strength is handed over for home training. If the calculated value is not a multiple of 5, since the product is a 5kg-step preparation, we will ask you to select a hand gripper that can be handed in two types, a heavier one and a lighter one. If it is lighter than 5 kg, we will ask you to choose from 5 kg and soft tennis balls.
For training at home, 10-12 grip exercises using a hand gripper should be repeated every 3 sets every day. About 20-30 days of training will be provided until the outpatient day immediately before surgery.
Control group
No specific therapeutic intervention.
60 | years-old | <= |
Not applicable |
Male and Female
1. Patients scheduled for valvular heart surgery
2. Patients scheduled for coronary artery bypass surgery
1.Patients who are currently being treated in a psychiatry due to a mental illness
2. Patients with a Mini-Mental State Examination score of 21 or less at registration
3. Patients who cannot speak daily conversation in Japanese
4.Patients who have entered the intensive care unit including other hospitals within a past year
5. Compared to the left and right side, patients with strong grip strength >30 kg for men and >20 kg for women
6.Patients with upper limb paralysis who cannot be gripped or trained
7. NYHA IV patients
8.Patients suspected to have symptomatic cerebral ischemia such as syncope due to exercise in the past
9. Patients who have not been extubated within 24 hours after surgery
10. Patients who have offered to withdraw consent after registration
11. Patients who died during surgery or was returned to the ICU after wearing the assisted heart-lung machine
12.Patients who were scheduled for coronary artery bypass surgery without cardiopulmonary bypass, but were treated with cardiopulmonary bypass by intraoperative judgment.
218
1st name | Yusuke |
Middle name | |
Last name | Naito |
Nara Medical University
Department of Anesthesiology
6348522
840 Sijocho Kashihara, Nara
0744-22-3051
schneider.yusuke@gmail.com
1st name | Yusuke |
Middle name | |
Last name | Naito |
Nara Medical University
Department of Anesthesiology
6348522
840 Sijocho Kashihara, Nara
0744-22-3051
schneider.yusuke@gmail.com
Nara Medical University
Nara Medical University
Other
Nara Medical University Bioethics Office
840 Sijocho Kashihara, Nara
0744-22-3051
ino_rinri@naramed-u.ac.jp
NO
2020 | Year | 08 | Month | 01 | Day |
Unpublished
Terminated
2019 | Year | 12 | Month | 21 | Day |
2020 | Year | 06 | Month | 10 | Day |
2020 | Year | 08 | Month | 01 | Day |
2023 | Year | 08 | Month | 07 | Day |
2023 | Year | 08 | Month | 07 | Day |
2023 | Year | 08 | Month | 07 | Day |
2023 | Year | 08 | Month | 07 | Day |
2020 | Year | 07 | Month | 28 | Day |
2023 | Year | 10 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045873
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