UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056997 |
|---|---|
| Receipt number | R000065140 |
| Scientific Title | Development and Evaluation of an Oral Care Protocol for Mechanically Ventilated Patients |
| Date of disclosure of the study information | 2025/02/15 |
| Last modified on | 2026/08/16 21:55:12 |
* 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
Development and Evaluation of an Oral Care Protocol for Mechanically Ventilated Patients
Acronym
OCP-MV
Scientific Title
Development and Evaluation of an Oral Care Protocol for Mechanically Ventilated Patients
Scientific Title:Acronym
OCP-MV
Region
| Japan |
Condition
Condition
VAP
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop, validate and utilize oral care protocols for intubated patients according to their oral assessment tool scores to improve the oral environment and reduce the incidence of VAP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral bacteria counts, oral humidity and OHAT scores during the observation period (days 1-3)
Key secondary outcomes
VAP incidence, duration on ventilator, days in ICU, days to start oral intake after extubation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Reinforce oral moisturizing care using a proprietary oral care protocol.
Interventions/Control_2
Normal oral care
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Time of hospitalization
Key exclusion criteria
Exclude patients who have been extubated within 48 hours of intubation, patients with oral or facial trauma, and patients who can perform oral care on their own. Patients diagnosed with pneumonia on admission or within 48 hours of admission are also excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiko |
| Middle name | |
| Last name | Sasaki |
Organization
Institute of Science Tokyo
Division name
Disaster Critical Care Nursing
Zip code
135-0044
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
ns220003@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Sato |
Organization
Institute of Science Tokyo
Division name
Disaster Critical Care Nursing
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
08053790803
Homepage URL
ns220003@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
JPMJSP2120
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
08053790803
ns220003@tmd.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
東京都
Institutions
Institutions
東京科学大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/nicc.70428
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/nicc.70428
Number of participants that the trial has enrolled
100
Results
Compared with the controls, the intervention group showed significantly better oral health on Day 3 (mean OHAT 1.88 vs. 5.20; oral moisture 20.4 vs. 6.6; bacterial counts 36.3 vs. 83.0; all p < 0.001). Ventilator duration and ICU stay were shorter in the intervention group (5.0 vs. 9.5 days, p < 0.001; 8.0 vs. 11.0 days, p = 0.006). PED incidence markedly reduced (4% vs. 46%; adjusted odds ratio 0.044, 95% confidence interval 0.009-0.209; number needed to treat = 3). Protocol adherence was 97.8%.
Results date posted
| 2026 | Year | 08 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 04 | Month | 10 | Day |
Baseline Characteristics
This quasi-experimental study was conducted between February and July 2025 in the emergency intensive care unit (ICU) of a university hospital.
Participant flow
After admission to the participating facility, informed consent was obtained from the patient or a family member.
Adverse events
No adverse events were observed.
Outcome measures
The primary outcomes were the 3-day OHAT score, oral moisture level, and oral bacterial count. Secondary outcomes included the duration of mechanical ventilation, ICU length of stay, and the incidence of ventilator-associated pneumonia (VAP), post-extubation delirium (PED), and ICU mortality.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 11 | Day |
Last modified on
| 2026 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065140
