UMIN-ICDS Clinical Trial

Public title

Association of Arterial Line Securement Devices With Hand Function in ICU Patients: A Multicenter Study

Acronym

Association of Arterial Line Securement Devices With Hand Function in ICU Patients: A Multicenter Study

Scientific Title

Association of Arterial Line Securement Devices With Hand Function in ICU Patients: A Multicenter Study

Scientific Title:Acronym

AFFIX study

Region

Japan

Condition

patients requiring intensive care

Classification by specialty

Emergency medicine

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to determine whether the use of arterial line (A-line) securement devices is associated with residual effects, such as reduced finger joint range of motion, pain, and discomfort during movement, at ICU discharge and hospital discharge.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Michigan Hand Outcomes Questionnaire, Japanese version (MHQ-J), at hospital discharge

Key secondary outcomes

Range of motion of the metacarpophalangeal (MCP) and wrist joints of both hands, grip strength, and time to unintentional arterial line (A-line) removal.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients aged 18 years or older who have a radial arterial line (A-line) inserted within 24 hours of ICU admission and are expected to require the arterial line for at least 24 hours. Patients who already have an arterial line at ICU admission are also eligible.

Key exclusion criteria

Patients meeting any of the following criteria will be excluded:

Patients expected to have a poor chance of survival

Patients expected to have a poor neurological prognosis

Patients with trauma

Patients with burns

Patients with joint deformities or diseases affecting hand function

Patients with neuromuscular disorders

Patients with a history of dementia

Patients with a history of hemiparesis

Patients unable to undergo grip strength measurement

Patients transferred from another hospital who may have already had an arterial line (A-line) placed at the referring hospital

Patients in whom the arterial line is inserted at a site not affecting wrist range of motion

Target sample size

235

Name of lead principal investigator

1st name	Tomoki
Middle name
Last name	Kuribara

Organization

Sapporo City University

Division name

School of Nursing

Zip code

060-0011

Address

Kita 11 Nishi 13, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-726-2500

Email

donguririn2000@yahoo.co.jp

Name of contact person

1st name	Tomoki
Middle name
Last name	Kuribara

Organization

Sapporo City University

Division name

School of Nursing

Zip code

060-0011

Address

Kita 11 Nishi 13, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-726-2500

Homepage URL

Email

donguririn2000@yahoo.co.jp

Institute

Sapporo City University

Institute

Department

Personal name

Tomoki Kuribara

Organization

Sapporo City University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Sapporo City University

Address

Geijutsu-no-Mori 1-chome, Minami-ku, Sapporo, Hokkaido 005-0864, Japan

Tel

011-592-2300

Email

pr@scu.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

東京大学（東京都）、一宮西病院（大阪府）、信州大学医学部附属病院（長野県）、東京都立墨東病院（東京都）、獨協医科大学病院（栃木県）、福岡赤十字病院（福岡県）、秋田大学医学部附属病院（秋田県）、長野市民病院（長野県）

Date of disclosure of the study information

2026

Year

03

Month

20

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

2025

Year

12

Month

25

Day

Date of IRB

Anticipated trial start date

2026

Year

06

Month

01

Day

Last follow-up date

2026

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a multicenter prospective observational study examining the association between the use of arterial line (A-line) securement devices and hand function in ICU patients. Patients aged 18 years or older who have a radial arterial line inserted within 24 hours of ICU admission will be included. The primary outcome is the Michigan Hand Outcomes Questionnaire, Japanese version (MHQ-J), assessed at hospital discharge. Secondary outcomes include range of motion of the finger and wrist joints, grip strength, and time to unintentional arterial line removal.

Registered date

2026

Year

03

Month

11

Day

Last modified on

2026

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069689