UMIN-CTR Clinical Trial

Public title

Critical care for prevention of deep-vein thrombosis and its psychoneurotic effects on patients

Acronym

Critical care for prevention of deep-vein thrombosis and its psychoneurotic effects on patients

Scientific Title

Critical care for prevention of deep-vein thrombosis and its psychoneurotic effects on patients

Scientific Title:Acronym

Critical care for prevention of deep-vein thrombosis and its psychoneurotic effects on patients

Region

Japan

Condition

patients with esophageal cancer in the intensive-care unit.

Classification by specialty

Gastrointestinal surgery

Intensive care medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study was to evaluate the effects of intermittent pneumatic compression (IPC) and leg massage which are used to prevent deep-vein thrombosis on blood or blood coagulation and to assess its psychoneurotic effects on patients with esophageal cancer in the intensive-care unit.
We believe that our study will lead nurses to give consideration to physical and psychological status of patients and to choose more effective way to prevent deep-vein thrombosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Measuring femoral venous blood flow 4 times: 0, 5, 15, and 30 minutes after the initiation of intervention.

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

IPC Group
After 30-minute or more time of IPC massage, starting the intervention by remaining the IPC, and the assessment items were measured. The following day, after 30-minute or more time of IPC massage, give massage to right lower leg for 5 minutes and remain with IPC for 25 minutes. Then the assessment items were measured.

Interventions/Control_2

Lower leg massage Group
After 30-minute or more time of IPC massage, give massage to right lower leg for 5 minutes and remain with IPC for 25 minutes. Then the assessment items were measured. The following day, after 30-minute or more time of IPC massage, starting the intervention by remaining the IPC, and the assessment items were measured.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

>20 years old
BMI<25
Blood pressure: 80-120mmHg within the range of +-20%
Pulse: 60-100 per minute within the range of +-20%
Body temperature :<38
Richmond Agitation-Sedation Scale (RASS) :from -1 to 0
Japan Coma Scale(JCS) (Appendix 5): <=2

Key exclusion criteria

Patient with a history of DVT
Patient with lost, wounded, or paralyzed right lower leg
Patient with estrogen treatment
Patient with heparin/warfarin treatment
Patient with coagulation defect (Antithrombin Deficiency, Protein C Deficiency, Protein S Deficiency, and Anti-phospholipid antibody syndrome)

Target sample size

24

Name of lead principal investigator

1st name
Middle name
Last name	Asami Tado

Organization

Yamaguchi University Graduate School of Medicine

Division name

Faculty of Health Science

Zip code

Address

1-1-1 Minani Kogushi, Ube, Yamaguchi

TEL

0836-22-2842

Email

asamik@yamaguchi-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Asami Tado

Organization

Yamaguchi University Graduate School of Medicine

Division name

Faculty of Health Science

Zip code

Address

1-1-1 Minani Kogushi, Ube, Yamaguchi

TEL

0836-22-2842

Homepage URL

Email

asamik@yamaguchi-u.ac.jp

Institute

Yamaguchi University Graduate School of Medicine

Institute

Department

Personal name

Organization

A donation

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

09

Month

12

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

Completed

Date of protocol fixation

2012

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

09

Month

12

Day

Last modified on

2013

Year

09

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013706