UMIN-CTR Clinical Trial

Basic information
Public title	An effect by abdominal position and the RTX(Clearance mode) combination for the infant intubated patients who had a diagnosis of a respiratory infectious disease and safe inspection of the patient ~Making and trial of the breathing care program~
Acronym	An effect by abdominal position and the RTX(Clearance mode) combination for the infant intubated patients who had a diagnosis of a respiratory infectious disease and safe inspection of the patient ~Making and trial of the breathing care program~
Scientific Title	An effect by abdominal position and the RTX(Clearance mode) combination for the infant intubated patients who had a diagnosis of a respiratory infectious disease and safe inspection of the patient ~Making and trial of the breathing care program~
Scientific Title:Acronym	An effect by abdominal position and the RTX(Clearance mode) combination for the infant intubated patients who had a diagnosis of a respiratory infectious disease and safe inspection of the patient ~Making and trial of the breathing care program~
Region	Japan

Condition
Condition	Severe pneumonia, respiratory syncytial virus infectious disease, human meta virus infectious diseases
Classification by specialty	Pneumology Pediatrics Intensive care medicine Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It was aimed for abdominal position and the evaluation of the effect by the RTX(Clearance mode) combination and the safe inspection of the patient. And I thought that I could connect a provided result with the unification of the nursing care by making a breathing care program for the cause.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[item evaluating abdominal position and an effect of RTX (clearance mode)] Data during an intubation period: I change the change of X-rays, blood test data, the instructions of the respiratory condition of it and compare the difference of data before and after the enforcement using mark order official approval of Wilcoxon belonging to in analysis during an intubation period [item evaluating safety] Presence of harm phenomena such as a flare of the skin with the practice, edema of the face, low blood pressure, tachycardia, the symptoms such as aspirations and accident extubation, tracheal intubation tube confinement by flexure and the secretion retention of the tracheal intubation tube, a tip status pulse route, an accident withdrawal or the flexure confinement of various drains
Key secondary outcomes	[item evaluating abdominal position and an effect of RTX (clearance mode)] 1)I investigate the days that I practiced from intubation day and the day when I introduced it 2)Basic data: Age of the patient, disease name, having underlying disease or not, the weight 3)Data before and after the enforcement of the patient: Vital signs, sedation depth (SBS), change of the amount of ventilation, change of change blood gas data of SpO2, EtCO2, 4)Data during an intubation period: I change the change of X-rays, blood test data, the instructions of the respiratory condition of it and compare the difference of data before and after the enforcement using mark order official approval of Wilcoxon belonging to in 3)analysis during an intubation period [item evaluating safety] 1)Presence of harm phenomena such as a flare of the skin with the practice, edema of the face, low blood pressure, tachycardia, the symptoms such as aspirations and accident extubation, tracheal intubation tube confinement by flexure and the secretion retention of the tracheal intubation tube, a tip status pulse route, an accident withdrawal or the flexure confinement of various drains

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	I carry out1cool RTX(clearance mode)between from 9:00 to 16:00. While I carry it out,I make abdominal position. 1)I perform the physique conversion in medical staff(doctor,nurse,physical ther apist)more than two 2)I do 5 RTX (clearance mode) counts 1 if cool (approximately ten minutes) Setting: 600 times of vibration /min (two minutes) INS PRESSURE (vibration intake pressure) -10 3)I avoid (just after infusion) just after a meal to take abdominal pressure, and to have possibilities to vomit
Interventions/Control_2
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	Not applicable
Age-upper limit	15 years-old >
Gender	Male and Female
Key inclusion criteria	The tracheal intubation patient who judged that I was hospitalized with a respiratory infectious disease (severe pneumonia, respiratory syncytial virus infectious disease, human meta virus infectious diseases), and a doctor needed abdominal position and the RTX (clearance mode) combination
Key exclusion criteria	The patient that an agreement was refused
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Ippei Middle name Last name Watanabe
Organization	Saitama Medical Center
Division name	PICU
Zip code	350-8550
Address	Saitama, Kawagoe-shi,Kamoda, 1981,
TEL	049-228-3864
Email	smcpicu@saitama-med.ac.jp

Public contact
Name of contact person	1st name Ippei Middle name Last name Watanabe
Organization	Saitama Medical Center
Division name	PICU
Zip code	350-8550
Address	Saitama, Kawagoe-shi,Kamoda, 1981,
TEL	049-228-3864
Homepage URL
Email	smcpicu@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center
Institute
Department

Funding Source
Organization	Saitama Medical Center
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	Saitama Medical Center
Address	Saitama, Kawagoe-shi,Kamoda, 1981,
Tel	049-228-3864
Email	smcpicu@saitama-med.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	2020 Year 03 Month 31 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	Preinitiation
Date of protocol fixation	2019 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date	2020 Year 03 Month 31 Day
Last follow-up date	2020 Year 08 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	2019 Year 09 Month 18 Day
Last modified on	2019 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043340