UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023426 |
|---|---|
| Receipt number | R000026989 |
| Scientific Title | EFFECT OF HIGH FLOW NASAL CANNULA ON THORACO-ABDOMINAL SYNCHRONY IN PEDIATRIC PATIENTS AFTER CARDIAC SURGERY |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2018/07/29 10:21:04 |
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Basic information
Public title
EFFECT OF HIGH FLOW NASAL CANNULA ON THORACO-ABDOMINAL SYNCHRONY IN PEDIATRIC PATIENTS AFTER CARDIAC SURGERY
Acronym
EFFECT OF HIGH FLOW NASAL CANNULA ON THORACO-ABDOMINAL SYNCHRONY IN PEDIATRIC PATIENTS AFTER CARDIAC SURGERY
Scientific Title
EFFECT OF HIGH FLOW NASAL CANNULA ON THORACO-ABDOMINAL SYNCHRONY IN PEDIATRIC PATIENTS AFTER CARDIAC SURGERY
Scientific Title:Acronym
EFFECT OF HIGH FLOW NASAL CANNULA ON THORACO-ABDOMINAL SYNCHRONY IN PEDIATRIC PATIENTS AFTER CARDIAC SURGERY
Region
| Japan |
Condition
Condition
Congenital heart disease
Classification by specialty
| Cardiovascular surgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are to see if high flow nasal cannula can improve:
1. Thoraco-abdominal snchrony
2. Oxygenation (increase in PaO2) and ventilation (reduction in respiratory frequency and PaCO2)
in post-cardiosurgical pediatric patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase angle calculated with values measured by respiratory inductive plethysmography as an index of thoraco-abdominal synchrony before HFNC therapy, 30 and 60 minutes after the start of HFNC therapy and 30 minutes after the end of HFNC therapy.
Key secondary outcomes
Respiratory frequency and results of arterial blood gas analysis
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Control: conventional oxygen therapy for 30 minutes
Interventions/Control_2
High flow oxygen therapy via nasal cannula for 60 minutes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
pediatric patients with body weights of 15 kg or less requiring oxygen therapy after extubation
Key exclusion criteria
Subjects with:
severe circulatory and respiratory failure
facial trauma
nasal congestion
tolerance for HFNC
consciousness disturbances with Glasgow Coma Scale of 12 or less
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayo Izawa |
Organization
The University of Tokukshima Graduate School
Division name
Emergency and Critical Care Medicine
Zip code
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-9347
taiga@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiga Itagaki |
Organization
The University of Tokukshima Graduate School
Division name
Emergency and Critical Care Medicine
Zip code
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-9347
Homepage URL
taiga@tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
self funding
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
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
| 2016 | Year | 08 | Month | 01 | 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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 01 | Day |
Last modified on
| 2018 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026989
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
