UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040749
Receipt number R000046524
Scientific Title Relationship between cerebral oxygenation response and vital signs at the time of first leaving bed in critically ill patients
Date of disclosure of the study information 2020/06/13
Last modified on 2023/12/19 22:26:02

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Basic information

Public title

Relationship between cerebral oxygenation reaction and vital signs at the time of first leaving bed in critically ill patients

Acronym

Relationship between cerebral oxygenation reaction and vital signs in critically ill patients

Scientific Title

Relationship between cerebral oxygenation response and vital signs at the time of first leaving bed in critically ill patients

Scientific Title:Acronym

Relationship between cerebral oxygenation reaction and vital signs in critically ill patients

Region

Japan


Condition

Condition

Critically ill patients admitted to the Emergency and Trauma Center

Classification by specialty

Intensive care medicine Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the association between changes in cerebral oxygenation response and outcome and other risk management indices in postural changes during initial mobilization in critically ill patients.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Outcome, Cerebral oxygenation during postural changes(Bed up position, sitting position)

Key secondary outcomes



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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who are admitted to a critical care/trauma center and undergo rehabilitation
2. Patients whose doctors decide to start bed based on clinical criteria
3. Patients who leave their bed for the first time while being admitted to a critical care/trauma center
4. Those who have obtained consent to participate in the research from the person or family in advance

Key exclusion criteria

1. Patients with body mass index over 35 kg/m2
2. NIRS probe not applicable
3. Cases of giving up active treatment

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Ryota
Middle name
Last name Imai

Organization

Uonuma kikan hospital

Division name

Department of Rehabilitation Medicine

Zip code

949-7302

Address

4132 Urasa, Minami Uonuma-shi, Niigata, Japan

TEL

025-777-3200

Email

imaryo1105@gmail.com


Public contact

Name of contact person

1st name Ryota
Middle name
Last name Imai

Organization

Uonuma kikan hospital

Division name

Department of Rehabilitation Medicine

Zip code

949-7302

Address

4132 Urasa, Minami Uonuma-shi, Niigata, Japan

TEL

025-777-3200

Homepage URL


Email

imaryo1105@gmail.com


Sponsor or person

Institute

Uonuma kikan hospital

Institute

Department

Personal name



Funding Source

Organization

Niigata University of Health and Welfare Applying

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

Uonuma kikan hospital Ethics Committee

Address

4132 Urasa, Minami Uonuma-shi, Niigata, Japan

Tel

025-777-3200

Email

rehabilitation@ncmi.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

魚沼基幹病院(新潟県)


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2020 Year 06 Month 02 Day

Date of IRB

2020 Year 06 Month 19 Day

Anticipated trial start date

2020 Year 06 Month 19 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cerebral oxygenation response (local cerebral oxygen saturation, oxygenated hemoglobin change, deoxygenated hemoglobin change, total hemoglobin change) is considered to correlate with vital signs in healthy subjects, and the disease state management and prognosis prediction of critically ill patients It is said to be useful for.


Management information

Registered date

2020 Year 06 Month 13 Day

Last modified on

2023 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046524


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name