UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029243 |
|---|---|
| Receipt number | 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 12:05:52 |
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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
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
nozomi_nariai@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Miyazaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033424
