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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029243
Receipt No. R000033424
Scientific Title To clarify the effect of foot bath using carbonated spring for patients wearing mechanical ventilator during sustained sedation / analgesia administration
Date of disclosure of the study information 2017/09/24
Last modified on 2017/09/22

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Basic information
Public title To clarify the effect of foot bath using carbonated spring for patients wearing mechanical ventilator during sustained sedation / analgesia administration
Acronym Effect of footbath using carbonated spring for respiratory patients
Scientific Title To clarify the effect of foot bath using carbonated spring for patients wearing mechanical ventilator during sustained sedation / analgesia administration
Scientific Title:Acronym Effect of footbath using carbonated spring for respiratory patients
Region
Japan

Condition
Condition All diseases that do not meet the start criteria
Classification by specialty
Intensive care medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of foot bath using carbonated spring for patients wearing ventilator during sustained sedation / analgesia administration.In addition, this study is conducted as academic research activities aimed at new knowledge in the field of acute care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood pressure
Key secondary outcomes Heart rate,Body temperature, Breathing frequency, Airway pressure,Tidal volume, SpO2, Level of consciousness, Amount of urine,SOFA score


Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Cases with fresh water foot bath preceding
Interventions/Control_2 Cases in which carbonated spring foot baths precede
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Breathing frequency 10 times / minute or less 40 times or more
Heart rate 50 times / minute or less 120 times / minute or more
Resting systolic blood pressure 80 mmHg or less 170 mm Hg or more
At resting diastolic blood pressure 120 mmHg or more
There is no appearance of arrhythmia at rest
SpO2 90% or more
There is no active gastrointestinal bleeding
Key exclusion criteria Patients not meeting the start criteria
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromi Oda
Organization Miyazaki University Medical School Hospital
Division name Intensive care unit
Zip code
Address Miyazaki Prefecture Miyazaki city Kiyohara cho 5200
TEL 0985-85-1536
Email nozomi_nariai@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nozomi Nariai
Organization Miyazaki University Medical School Hospital
Division name Intensive care unit
Zip code
Address Miyazaki Prefecture Miyazaki city Kiyohara cho 5200
TEL 0985-85-1536
Homepage URL
Email nozomi_nariai@med.miyazaki-u.ac.jp

Sponsor
Institute Miyazaki University
Institute
Department

Funding Source
Organization Miyazaki University
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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 24 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 22 Day
Last modified on
2017 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033424

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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