UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060544 |
|---|---|
| Receipt number | R000069257 |
| Scientific Title | Evaluation of the Efficacy of a Thirst Care Bundle for Tracheally Intubated Patients |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/02/01 10:49:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the Efficacy of a Thirst Care Bundle for Tracheally Intubated Patients
Acronym
Evaluation of the Efficacy of a Thirst Care Bundle for Tracheally Intubated Patients
Scientific Title
Evaluation of the Efficacy of a Thirst Care Bundle for Tracheally Intubated Patients
Scientific Title:Acronym
Evaluation of the Efficacy of a Thirst Care Bundle for Tracheally Intubated Patients
Region
| Japan |
Condition
Condition
Intubated patient
Classification by specialty
| Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the change in the effect on thirst sensation by introducing a thirst care bundle compared to conventional thirst care in patients undergoing oral intubation during ICU admission, using a before-and-after comparative study. The results of this study suggest that establishing effective care methods for the thirst reported by orally intubated patients in the ICU could not only alleviate this discomfort but also potentially prevent complications like delirium, where thirst acts as an inducing or aggravating factor. This is considered an important finding that could lead to improved patient quality of life (QOL) and enhanced patient safety management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint
Xerostomia NRS when comparing conventional xerostomia care with the xerostomia care bundle
Key secondary outcomes
Secondary endpoint
Association between xerostomia NRS and the occurrence of delirium the following day
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention consisted of applying approximately 3 g of an oral moisturizing gel to the entire oral mucosa using a swab after routine oral care, and massaging the oral cavity with frozen, solution-impregnated oral swabs containing glycerin, sorbitol, and peppermint essence. A menthol-containing lip balm was applied to the lips in a 1 to 2 mm layer, and a nonwoven mask was worn over the mouth to prevent oral dryness (kept on at all times except during oral care and communication). The solution-impregnated swabs and lip balm were provided without a limit upon the patient's request. Before each oral care session, thirst was assessed using a 0 to 10 numeric rating scale, and before the pre-6 a.m. oral care session, oral moisture was measured with a moisture checker and oral dryness was evaluated using the Revised Oral Assessment Guide. The duration of oral care and the number of swabs used were recorded. The intervention was continued throughout the intubation period, and discontinued if deepened sedation made NRS assessment infeasible.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligible participants are ICU patients aged 18 years or older who are orally intubated, have a Richmond Agitation-Sedation Scale (RASS) score of 0 to -2, and can communicate verbally in some form, such as using a communication board.
Key exclusion criteria
Patients are excluded if any of the following apply: severe oral mucosal or lip lesions preventing routine oral care; inability to perform oral cleansing; trismus limiting oral care; impaired consciousness or otherwise difficult communication; Glasgow Coma Scale score <10; inability to communicate nonverbally; nausea or vomiting; inability to self-report; clear refusal to participate; or an active Do Not Attempt Resuscitation (DNAR) order.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Haruna |
Organization
sapporo medical university hospital
Division name
ICU
Zip code
0608543
Address
sapporo
TEL
0116112111
jp.haruna@hotmail.co.jp
Public contact
Name of contact person
| 1st name | JUMPEI |
| Middle name | |
| Last name | HARUNA |
Organization
Sapporo medical university
Division name
ICU
Zip code
060
Address
sapporo
TEL
0116112111
Homepage URL
jp.haruna@hotmail.co.jp
Sponsor or person
Institute
Sapporo medical university
Institute
Department
Personal name
Junpei haruna
Funding Source
Organization
sapporo medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo medical university hospital
Address
Sapporo
Tel
0116112111
jp.haruna@hotmail.co.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
北海道
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 01 | 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
| 2025 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 01 | Day |
Last modified on
| 2026 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069257
