UMIN-CTR Clinical Trial

Basic information
Public title	The effect of oral care using a oral care kit and the oral care application on endotracheal intubation patients
Acronym	The effect of oral care using a oral care kit and the oral care application on endotracheal intubation patients
Scientific Title	The effect of oral care using a oral care kit and the oral care application on endotracheal intubation patients
Scientific Title:Acronym	The effect of oral care using a oral care kit and the oral care application on endotracheal intubation patients
Region	Japan

Condition
Condition	Patients undergoing intensive care
Classification by specialty	Intensive care 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 a oral care kit and the oral care application for intubated patients will keep oral environment cleaner and decrease silent aspiration more than that with running 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,5days later and extubation day.
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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	oral care using a oral care kit and the oral care application Group Using a oral care kit and the oral care application for oral care.
Interventions/Control_2	Control Group Usual 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	Patient with cuffed intratracheal tube Patient with permanent teeth (one or more teeth) After written consent was obtained from patient or family Gender is no object.
Key exclusion criteria	Patient with a history of antibacterial drug use within three months of being admitted. Patient with a history of 5-and more-day hospitalization within three month of being admitted. Patient with oral disease Patient with the possibility of gum bleeding by brushing.
Target sample size	240

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	0836-22-2842
Email	asamik@yamaguchi-u.ac.jp

Public contact
Name of contact person	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	0836-22-2842
Homepage URL
Email	asamik@yamaguchi-u.ac.jp

Sponsor
Institute	The field of clinical nursing
Institute
Department

Funding Source
Organization	Grant-in-Aid for Young Scientists B
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
Address
Tel
Email

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	2016 Year 03 Month 10 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	2015 Year 07 Month 17 Day
Date of IRB	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 03 Month 10 Day
Last follow-up date	2019 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 03 Month 09 Day
Last modified on	2020 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024700