UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055470 |
|---|---|
| Receipt number | R000058870 |
| Scientific Title | The Effect of High-Flow Nasal Cannula Oxygen Therapy on Respiratory Muscle |
| Date of disclosure of the study information | 2024/09/11 |
| Last modified on | 2025/03/13 12:21:50 |
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Basic information
Public title
The Effect of High-Flow Nasal Cannula Oxygen Therapy on Respiratory Muscle
Acronym
The Effect of High-Flow Nasal Cannula Oxygen Therapy on Respiratory Muscle
Scientific Title
The Effect of High-Flow Nasal Cannula Oxygen Therapy on Respiratory Muscle
Scientific Title:Acronym
The Effect of High-Flow Nasal Cannula Oxygen Therapy on Respiratory Muscle
Region
| Japan |
Condition
Condition
Patients 18 years of age or older for whom HFNC is considered appropriate at the time of consent. Patients with acute respiratory failure (PaO2/FIO2<300, SpO2<92%, etc. requiring oxygenation). High risk post extubation (age > 65 years, chronic heart failure, APACHE II score > 12, BMI > 30, airway problems, difficult weaning, duration of ventilator management > 7 days). Post thoracic surgery (ARISTAT score > 26 points, obesity, high risk of cardiac and pulmonary disease).
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate respiratory muscle thickness changes in patients using HFNC before and after its use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The results of this study will evaluate the changes in DTei, DTee, ETei, ETee, DTF, ETF, DTF/respiratory rate, and ETF/respiratory rate before and after wearing HFNC as changes in respiratory effort. In addition, the relationship between inspiratory and expiratory muscles will be evaluated.
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Acute respiratory failure (PaO2/FIO2<300, SpO2<92%, etc., requiring oxygenation)
Post-extubation high risk (age > 65 years, chronic heart failure, APACHE II score > 12, BMI > 30, airway problems, difficult weaning, duration of ventilator management > 7 days, one or more of the following)
and post thoracic surgery (ARISTAT score > 26 points, obesity, high risk of cardiac and pulmonary disease)
Key exclusion criteria
Highly obese (BMI>40), pregnant women, history of neuromuscular disease, cervical cord injury or post-surgical spinal cord injury, abdominal obstruction, post-tracheostomy, severe COPD, overactive delirium, agitation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Taiga |
| Middle name | |
| Last name | Itagaki |
Organization
Tokushima University Hospital
Division name
Department of Emergency and Intensive Care Medicine
Zip code
770-8503
Address
Tokushima ,Tokushima city, Kuramoto town, 2-50-1
TEL
0886313111
tigerusan@gmail.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Takashima |
Organization
Tokushima University Hospital
Division name
Department of Emergency and Intensive Care Medicine
Zip code
7708503
Address
Tokushima ,Tokushima city, Kuramoto town, 2-50-1
TEL
0886313111
Homepage URL
t.takashima0405@gmail.com
Sponsor or person
Institute
Tokushima University
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 Hospital
Address
Tokushima ,Tokushima city, Kuramoto town, 2-50-1
Tel
0886313111
t.takashima0405@gmail.com
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
| 2024 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
30
Results
We're analyzing all of the data
Results date posted
| 2024 | Year | 09 | Month | 10 | Day |
Results Delayed
Results Delay Reason
We're analyzing all of the data
Date of the first journal publication of results
Baseline Characteristics
Admitted to ICU and required HFNC
Participant flow
Subjects wear HFNC and are evaluated by diaphragmatic echocardiography.
Adverse events
none
Outcome measures
Diaphragm function and its changes
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 09 | Month | 10 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058870
