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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040029
Receipt No. R000045570
Scientific Title Effects of Menthol on thirst in ICU patients: An exploratory randomized clinical trial
Date of disclosure of the study information 2020/04/02
Last modified on 2020/04/02

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Basic information
Public title Effects of Menthol on thirst in ICU patients: An exploratory randomized clinical trial
Acronym Effects of Menthol on thirst in ICU patients: An exploratory randomized clinical trial
Scientific Title Effects of Menthol on thirst in ICU patients: An exploratory randomized clinical trial
Scientific Title:Acronym ICU-thirst
Region
Japan

Condition
Condition ICU patients
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to exploratively evaluate the efficacy of menthol in ICU patients undergoing abstinence from eating and drinking by comparing whether menthol in mouthwash or swab cleansing reduces dry mouth with tap water.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective Thirst Analog Scale Immediately After Oral Care Implementation
Key secondary outcomes The number of hours of oral care the patient wanted after implementation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Non-intubated patients should gargle with menthol water three times in sequence. Intubate patients are wiped three times consecutively with a swab of menthol water.
Interventions/Control_2 Non-intubated patients should gargle with water three times in sequence. Intubate patients are wiped three times consecutively with a swab of water.
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 1)Adult patients who have given written consent to participate in the study
2)Patients scheduled to be admitted to the ICU or admitted as an emergency
3)The period of prohibited eating and drinking is longer than 24 hours.
4)GCS:E3V5(T)M6, sedation depth at RASS 0. Patients who can communicate.
5)Patients who do not have ulcers in their mouths or who do not have the potential for pain.
6)Patients who do not have a problem with menthol
Key exclusion criteria 1)Blood sodium concentration is 150 mEq/L or more
2)Patients who have difficulty communicating in Japanese and reading and writing in Japanese
3)Patients whose inclusion in the study is deemed inappropriate by the investigators.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ayumi
Middle name
Last name Sakamoto
Organization Center Hospital of the National Center for Global Health and Medicine
Division name ICU
Zip code 162-8655
Address 1-21-1 Toyama Shinjuku-ku, Tokyo
TEL 03-3202-7181
Email asakamoto@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Aya
Middle name
Last name Umeda
Organization Center Hospital of the National Center for Global Health and Medicine
Division name Nursing department
Zip code 162-8655
Address 1-21-1 Toyama Shinjuku-ku, Tokyo
TEL 03-3202-7181
Homepage URL
Email aumeda@hosp.ncgm.go.jp

Sponsor
Institute ICU, Center Hospital of the National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization nothing
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 National Center for Global Health and Medicine Ethics Board
Address 1-21-1 Toyama Shinjuku-ku, Tokyo
Tel 03-3202-7181
Email rinrijm@hosp.ncgm.go.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 国立国際量研究センター病院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 02 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 02 Month 24 Day
Date of IRB
2020 Year 03 Month 13 Day
Anticipated trial start date
2020 Year 04 Month 10 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 02 Day
Last modified on
2020 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045570

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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