UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057899 |
|---|---|
| Receipt number | R000066176 |
| Scientific Title | Effect of oral application of povidone-iodine on the number of bacteria entering the lower respiratory tract of intubated patients |
| Date of disclosure of the study information | 2025/05/19 |
| Last modified on | 2025/05/19 07:35:09 |
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Basic information
Public title
Effect of oral application of povidone-iodine on the number of bacteria entering the lower respiratory tract of intubated patients
Acronym
Effect of oral application of povidone-iodine on the number of bacteria entering the lower respiratory tract of intubated patients
Scientific Title
Effect of oral application of povidone-iodine on the number of bacteria entering the lower respiratory tract of intubated patients
Scientific Title:Acronym
Effect of oral application of povidone-iodine on the number of bacteria entering the lower respiratory tract of intubated patients
Region
| Japan |
Condition
Condition
Intubated patients with cuffed tracheostomy tubes
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ventilator-associated pneumonia (VAP) may occur in intubated patients due to the influx of oropharyngeal reservoirs containing pathogenic microorganisms into the lower airway. The purpose of this study was to determine whether appropriate oral care can reduce the number of bacteria on the cuff of the intubation tube.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total bacteria in cuff upper reservoir by Real-time PCR
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Isodine application group
Interventions/Control_2
Brushing group
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) A cuffed tracheal cannula is in place
2) Age at least 18 years old at the time consent is obtained
3) Gender: any gender
4) Name of disease: No questions asked
5) Patients who have received a thorough explanation of their participation in this study,and who have obtained the free and voluntary consent of the research subject or the research subject's surrogate, based on a thorough understanding of the subject's condition.
Key exclusion criteria
1) edentulous jaw
2) History of iodine allergy
3) Patients who have refused to participate in this study
4) Other patients deemed inappropriate as research subjects by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sakamoto |
Organization
Kansai meical university medical center
Division name
Oral surgery
Zip code
5708507
Address
10-15Fumizono-cyo Moriguchi-shi Osaka-fu
TEL
09086076285
s.yukioutdoor@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sakamoto |
Organization
Kansai medical university medical center
Division name
Oral surgery
Zip code
5708507
Address
10-15Fumizono-cyo Moriguchi-shi Osaka-fu
TEL
09086076285
Homepage URL
s.yukioutdoor@gmail.com
Sponsor or person
Institute
Kansai medical university
Institute
Department
Personal name
Yuki Sakamoto
Funding Source
Organization
Kansai medical 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
Kansai Medical University Medical Center
Address
10-15 Fumizono-cho Moriguchi-shi
Tel
0669939420
s.yukioutdoor@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
大阪府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 19 | 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
20
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
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2025 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066176
