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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023426
Receipt No. 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

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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
Email 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
Email taiga@tokushima-u.ac.jp

Sponsor
Institute The University of Tokushima Graduate School
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name


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