UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046663 |
|---|---|
| Receipt number | R000053194 |
| Scientific Title | Verification of the effect of oral care wet sheets on oral tracheal intubation patients |
| Date of disclosure of the study information | 2022/01/17 |
| Last modified on | 2023/03/08 10:04:28 |
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Basic information
Public title
Verification of the effect of oral care wet sheets on oral tracheal intubation patients
Acronym
Verification of the effect of oral care wet sheets on oral tracheal intubation patients
Scientific Title
Verification of the effect of oral care wet sheets on oral tracheal intubation patients
Scientific Title:Acronym
Verification of the effect of oral care wet sheets on oral tracheal intubation patients
Region
| Japan |
Condition
Condition
All diseases that require oral tracheal intubation
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For oral tracheal intubation patients, we will compare the current sponge brush with a wet sheet for oral care to clarify which can remove contaminants and reduce oral care time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of oral bacteria and ATP are measured and compared before oral care, after brushing, and after oral care, respectively, in the sponge brush group and the wet sheet group for oral care.
In addition, the time it takes to wipe off the sponge brush and the wet sheet for oral care is measured and compared.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Sheets
Oral care method using wet sheets for oral care to remove contaminants
Interventions/Control_2
Control group (sponge brush group)
Oral care method using sponge brush to remove pollutants (daily medical care of our center)
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
Regardless of gender
Any type of intubation tube
Patients with oral care by nurses
a patient with one or more auto-teeth
a patient with consent from the person or an on-behalf
Key exclusion criteria
Patients with oral diseases (traumatic damage, oral hemorrhage, etc.)
Patients who do not have the permission of the attending physician or the doctor in charge
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sasaki |
Organization
Yamaguchi University Hospital
Division name
Nursing Department Building A 1st floor
Zip code
755-8505
Address
1-1-1 Minami Kogushi, Ube, Yamaguchi
TEL
0836-22-2773
akira@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Sasaki |
Organization
Yamaguchi University Hospital
Division name
Nursing Department Building A 1st floor
Zip code
755-8505
Address
1-1-1 Minami Kogushi, Ube, Yamaguchi
TEL
0836-22-2773
Homepage URL
akira@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants for Scientific Research Fees Fundamental Research C
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamaguchi University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi University Hospital Pharmaceutical Trial/Clinical Research Review Committee
Address
1-1-1 Minami Kogushi, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-u.ac.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
山口大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
56
Results
No significant difference was observed in changes in the number of bacteria between the sponge brush group and the sheet group. Both groups showed a decrease in the number of bacteria after oral care. The wiping time was significantly longer in the sheet group.
Results date posted
| 2023 | Year | 03 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 24 subjects were analyzed, including 15 males and 9 females.
Participant flow
Adverse events
none
Outcome measures
Number of bacteria, number of sheets, wiping time, interview survey
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 17 | Day |
Last modified on
| 2023 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053194
