UMIN-ICDS Clinical Trial

Public title

Development of an Algorithm for Determining Rehabilitation Interventions Based on Cognitive Function Assessments in ICU Patients Who Underwent Open-Chest Surgery: A Multicenter Prospective Study

Acronym

Development of a Rehabilitation Intervention Algorithm Based on Cognitive Function Assessments of Critically Ill Patients

Scientific Title

Development of an Algorithm for Determining Rehabilitation Interventions Based on Cognitive Function Assessments in ICU Patients Who Underwent Open-Chest Surgery: A Multicenter Prospective Study

Scientific Title:Acronym

Development of a Rehabilitation Intervention Algorithm Based on Cognitive Function Assessments of Critically Ill Patients

Region

Japan

Condition

Patients who underwent open-chest surgery and were admitted to the ICU

Classification by specialty

Cardiovascular surgery	Intensive care medicine	Rehabilitation medicine
Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To develop a hierarchical decision-making algorithm that integrates levels of consciousness (RASS), delirium (CAM-ICU), and cognitive function (OCS), with intervention targets based on the clinical judgment of occupational therapists as the outcome variables, and to verify its validity.
1. Feasibility of the OCS in ICU patients (with particular focus on its relationship to level of consciousness)
2. Validity of the OCS (in relation to existing cognitive function assessments and delirium assessments)
3. Development of a decision-making algorithm integrating the RASS, CAM-ICU, and OCS
4. Validation of the classification performance and clinical outcome prediction ability of the developed algorithm

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

oxford cognitive screen: OCS

Key secondary outcomes

Montreal Cognitive Assessment (MoCA-J)
Glasgow Coma Scale (GCS)
Richmond Agitation-Sedation Scale (RASS)
Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Muscle Strength Assessment Using the MRC Scale (MRC-sum score)
Functional Status Score for the Intensive Care Unit (FSS-ICU)
Borg Scale
Numerical Rating Scale (NRS)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients who underwent thoracotomy and were admitted to the ICU
Patients aged 20 years or older and younger than 90 years
Patients with no history of neurological disease, dementia, or psychiatric disorder
Patients with no prior history of the same disease
Patients without tracheostomy

Key exclusion criteria

Patients younger than 20 years or aged 90 years or older
Patients with missing data that prevent analysis
Patients whose ICU stay was 24 hours or less
Patients with difficulty understanding or expressing Japanese
Patients who do not provide consent to participate

Target sample size

500

Name of lead principal investigator

1st name	Takayuki
Middle name
Last name	Miyauchi

Organization

Shonan University of Medical Sciences

Division name

Occupational Therapy Course, Department of Rehabilitation, Faculty of Health Sciences

Zip code

244-0806

Address

16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

TEL

0458210111

Email

takayuki.miyauchi@sums.ac.jp

Name of contact person

1st name	Takayuki
Middle name
Last name	Miyauchi

Organization

Shonan University of Medical Sciences

Division name

Occupational Therapy Course, Department of Rehabilitation, Faculty of Health Sciences

Zip code

244-0806

Address

16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

TEL

0458210111

Homepage URL

Email

takayuki.miyauchi@sums.ac.jp

Institute

Shonan University of Medical Sciences

Institute

Department

Personal name

Takayuki Miyauchi

Organization

Shonan University of Medical Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shonan University of Medical Sciences

Address

16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

Tel

0458210111

Email

takayuki.miyauchi@sums.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

聖マリアンナ医科大学横浜市西部病院（神奈川），名古屋大学医学部附属病院（愛知），心臓病センター榊原病院（岡山），信州大学医学部附属病院（長野）

Date of disclosure of the study information

2026

Year

11

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

09

Month

15

Day

Date of IRB

2026

Year

09

Month

15

Day

Anticipated trial start date

2027

Year

04

Month

01

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The trial will begin after it has been approved by the ethics review committees at each study site.

Registered date

2026

Year

11

Month

05

Day

Last modified on

2026

Year

11

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072707