UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038082 |
|---|---|
| Receipt number | R000041380 |
| Scientific Title | The effect of High Flow Nasal Cannula on diaphragm function |
| Date of disclosure of the study information | 2019/09/25 |
| Last modified on | 2024/03/27 10:17:03 |
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Basic information
Public title
The effect of High Flow Nasal Cannula on diaphragm function
Acronym
The effect of High Flow Nasal Cannula on diaphragm function
Scientific Title
The effect of High Flow Nasal Cannula on diaphragm function
Scientific Title:Acronym
The effect of High Flow Nasal Cannula on diaphragm function
Region
| Japan |
Condition
Condition
respiratory failure
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesized that High Flow Nasal Cannula (HFNC) can contribute to diaphragm function since it washes out carbon dioxide in anatomical dead space, increases lung volume, and decreases the work of breathing. In this study, we evaluated the relationship between HFNC and diaphragm function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TF (Thickening Fraction) and DE (Diaphragm Excursion).
Key secondary outcomes
vital sign
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
We included adult patients who were admitted to the ICU and treated with HFNC.
Key exclusion criteria
Pneumothorax and paralysis of phrenic nerve.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Oto |
| Middle name | |
| Last name | Jun |
Organization
Emergency & Critical Care Medicine
Division name
Tokushima University Hospital.
Zip code
770-8503
Address
Tokushima prefecture, Tokushima city, Kuramoto 2-50-1
TEL
088-631-3111
joto@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Takashima |
Organization
Tokushima University Hospital.
Division name
Emergency & Critical Care Medicine
Zip code
770-8503
Address
Tokushima prefecture, Tokushima city, Kuramoto 2-50-1
TEL
088-631-3111
Homepage URL
t.takashima0405@gmail.com
Sponsor or person
Institute
Tokushima University Hospital.
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokushima University Clinical Trial Management Center
Address
Tokushima prefecture, Tokushima city, Kuramoto 2-50-1
Tel
088-631-3111
first-ec@tokushima-u.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
徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
http://www.tuh-ericu.org/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.tuh-ericu.org/
Number of participants that the trial has enrolled
40
Results
we found in some patients diaphragm showed paradoxical movement after liberation from HFNC. Three patients newly showed paradoxical movement, and two patients showed worsened paradoxical movement. We considered HFNC may play some role to prevent paradoxical movement of diaphragm.
Results date posted
| 2019 | Year | 09 | Month | 23 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
We couldn't collect cases on time.
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Patients with HFNC in ICU
Participant flow
none
Adverse events
none
Outcome measures
TF and DE
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 09 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041380
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
