UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038038 |
|---|---|
| Receipt number | R000043340 |
| 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~ |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2019/09/18 14:28:36 |
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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
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
smcpicu@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043340
