UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To clarify the effect of foot bath using carbonated spring for patients wearing mechanical ventilator during sustained sedation / analgesia administration
Title of the study (Brief title)	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	Hiromi Oda
Organization	Miyazaki University Medical School Hospital
Division name	Intensive care unit
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	Nozomi Nariai
Organization	Miyazaki University Medical School Hospital
Division name	Intensive care unit
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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