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 | 2026/04/10 03:49:29 |
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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
Thirty patients were enrolled, and all completed the study without adverse events. For the primary outcome, the thickening fraction of the lateral abdominal muscles (TFABD) did not differ from baseline at HFNC flows of 30, 40, or 50 L/min. In contrast, diaphragm thickening fraction (TFdi) significantly decreased at 50 L/min. In exploratory analyses, TFABD decreased at 40 and 50 L/min in patients with high baseline TFABD.
Results date posted
| 2024 | Year | 09 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study population comprised adult ICU patients at Tokushima University Hospital who required high-flow nasal cannula (HFNC) therapy for acute hypoxemic respiratory failure, high risk of extubation failure, or impaired gas exchange after cardiac surgery. Among the 30 enrolled participants, 22 (73%) were male. The mean age was 69 years (SD 13), and the mean body mass index was 23.1 kg/m2 (SD 3.6). Twenty-five participants (83%) had a Charlson comorbidity index of 2 or higher. The indications for HFNC were high risk of extubation failure in 17 patients (57%), post-cardiac surgery respiratory support in 12 (40%), and acute hypoxemic respiratory failure in 1 (3%). The mean PaO2/FIO2 ratio was 329 (SD 84), and the mean SOFA score on the day of extubation was 6 (SD 3).
Participant flow
Between November 2021 and December 2023, 664 ICU patients were screened, and 260 met the eligibility criteria. Of these, 30 patients were enrolled. All enrolled participants completed the study protocol. This was a single-center randomized crossover trial in which each participant underwent baseline assessment under low-flow oxygen, followed by HFNC at 30, 40, and 50 L/min in random order for 15 minutes each. There were no dropouts or protocol discontinuations.
Adverse events
No adverse events were observed in any of the 30 participants who completed the study protocol. No serious adverse events, treatment discontinuations, or safety concerns related to the study intervention were reported.
Outcome measures
The primary outcome was the change in the thickening fraction of the lateral abdominal muscles (TFABD) across the three HFNC flow settings as an index of expiratory muscle activity.
The secondary outcomes were changes in diaphragm thickening fraction (TFdi), individual expiratory muscle thickening fractions (TFIO, TFEO, TFTrA, and TFRA), and respiratory and hemodynamic variables, including breathing frequency, SpO2, FIO2, ROX index, heart rate, and blood pressure.
For the primary outcome, TFABD did not differ significantly from baseline at any HFNC flow setting in the overall cohort. In contrast, TFdi significantly decreased at 50 L/min compared with baseline (13% vs. 25%, p = 0.042). In exploratory analyses, participants with baseline TFABD greater than 10% showed significant reductions in TFABD at 40 and 50 L/min.
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
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
| 2026 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 10 | Day |
Date analysis concluded
| 2026 | Year | 04 | Month | 10 | Day |
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058870
