UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028307 |
|---|---|
| Receipt number | R000032402 |
| Scientific Title | The study of oral care methods of mechanically ventilated patients:prospective intervention study |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2021/09/20 18:04:08 |
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Basic information
Public title
The study of oral care methods of mechanically ventilated patients:prospective intervention study
Acronym
oral care of mechanically ventilated patients
Scientific Title
The study of oral care methods of mechanically ventilated patients:prospective intervention study
Scientific Title:Acronym
oral care of mechanically ventilated patients
Region
| Japan |
Condition
Condition
ventilator-associated pneumonia(VAP)
Classification by specialty
| Pneumology | Infectious disease | Intensive care medicine |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of the oral care methods, removal of tongue coating and using antiseptic after irrigation of oral cavity, in mechanically ventilated patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The total number of bacteria in the oropharyngeal fluid
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
intervention:removal of tongue coating by using 3% hydrogen peroxide
Interventions/Control_2
intervention:removal of tongue coating by using 3% hydrogen peroxide, next 5ml of 10% povidone iodine is dropped in oropharynx after irrigation
Interventions/Control_3
intervention:removal of tongue coating by using 3% hydrogen peroxide, next 5ml of 0.05% chlorhexidine is dropped in oropharynx after irrigation
Interventions/Control_4
control:general oral care in ICU
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
mechanically ventilated patients in ICU
Key exclusion criteria
1. patinets who is difficult to doing oral care because of getting worse in general condition
2. patients who have allergy to used antiseptic
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Saki |
| Middle name | |
| Last name | Hayashida |
Organization
Nagasaki university hospital
Division name
Oral and maxillofacial surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki 852-8588, Japan
TEL
095-819-7698
sakihaya@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Hayashida |
Organization
Nagasaki university hospital
Division name
Oral and maxillofacial surgery
Zip code
gaibushikin@ml.nagasaki-u.ac.jp
Address
1-7-1 Sakamoto, Nagasaki 852-8588, Japan
TEL
095-819-7698
Homepage URL
sakihaya@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university hospital
Institute
Department
Personal name
Funding Source
Organization
self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The IN
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
95-819-7229
gaibushikin@ml.nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000032402
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32093667/
Number of participants that the trial has enrolled
23
Results
After irrigation of the oral cavity, the number of bacteria decreased, but increased again at 1 hour after oral care in the control group; however, in the intervention group, the concentration of bacteria was significantly lower than that in the control group at one, 2 and 3 hours after oral care. The growth of all bacterial species tested was inhibited in the intervention group at 3 hours after oral care.
Results date posted
| 2021 | Year | 09 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who received mechanical ventilation in the intensive care unit of Nagasaki University Hospital between April and September 2018.
Participant flow
Oral care consisted of wiping with 3% hydrogen peroxide and irrigation with 200 mL of tap water plus suction. The patients in the intervention group received 5 mL of 10% povidone iodine applied topically in the oral cavity.
Adverse events
none
Outcome measures
Total number of bacteria in pharyngeal fluid
Increase / decrease in the number of bacteria by time series
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2017 | Year | 07 | Month | 20 | Day |
Last modified on
| 2021 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032402
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
