UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008713 |
|---|---|
| Receipt number | R000010240 |
| Scientific Title | Effects of oral care using moisturizing gel for intubated patients in emergency and its influences to nursing care |
| Date of disclosure of the study information | 2012/08/17 |
| Last modified on | 2014/03/17 10:09:00 |
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Basic information
Public title
Effects of oral care using moisturizing gel for intubated patients in emergency and its influences to nursing care
Acronym
Effects of oral care using moisturizing gel for intubated patients in emergency and its influences to nursing care
Scientific Title
Effects of oral care using moisturizing gel for intubated patients in emergency and its influences to nursing care
Scientific Title:Acronym
Effects of oral care using moisturizing gel for intubated patients in emergency and its influences to nursing care
Region
| Japan |
Condition
Condition
emergency patient
Classification by specialty
| Emergency medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify that the oral care using moisturizing gel for intubated patients will keep oral environment cleaner and decrease silent aspiration more than that with running water.
Another purpose was too clarify that the oral care using moisturizing gel will reduce more time and labor of nurses than that with tap water.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharyngeal mucus and sputum by intratracheal aspiration were obtained three times: soon after intubation, three days (48 hours) later, and 5 days (96 hours) later.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Moisturizing care Group
Using moisturizing gel for oral care.
Interventions/Control_2
Control Group
Using tap water for 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient hospitalized directly to the center (>20 years old)
2. Orally-intubated patient on the ventilator for more than one day
3. Patient with cuffed intratracheal tube
4. Patient with no evidence of pneumonia
5. Patient with permanent teeth (one or more teeth)
6. After written consent was obtained from patient or family
7. Gender is no object.
Key exclusion criteria
1. Patient with a history of antibacterial drug use within three months of being admitted.
2. Patient with a history of 5-and more-day hospitalization within three month of being admitted.
3. Patient with oral disease
4. Patient with the possibility of gum bleeding by brushing.
5. Patient with sinusitis
6. Patient with neck abscess
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asami Tado |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Faculty of Health Science
Zip code
Address
1-1-1 Minami Kogushi, Ube, Yamaguchi
TEL
0833-22-2842
asamik@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | asamitado |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Faculty of Health Science
Zip code
Address
1-1-1 Minami Kogushi, Ube, Yamaguchi
TEL
0836-22-2842
Homepage URL
asamik@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Young Scientists(B)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 08 | Month | 17 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 17 | Day |
Last modified on
| 2014 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010240
