UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061356 |
|---|---|
| Receipt number | R000070202 |
| Scientific Title | Evaluation of the sustained physiological effects of high-flow nasal cannula in stable post-extubation patients: A randomized crossover trial comparing with conventional oxygen therapy via nasal cannula |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/22 20:18:41 |
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Basic information
Public title
A study investigating the persistence of respiratory effects of high-flow nasal cannula (HFNC) in stable post-extubation patients
Acronym
A study investigating the persistence of respiratory effects of high-flow nasal cannula (HFNC) in stable post-extubation patients
Scientific Title
Evaluation of the sustained physiological effects of high-flow nasal cannula in stable post-extubation patients: A randomized crossover trial comparing with conventional oxygen therapy via nasal cannula
Scientific Title:Acronym
Evaluation of the sustained physiological effects of high-flow nasal cannula in stable post-extubation patients: A randomized crossover trial comparing with conventional oxygen therapy via nasal cannula
Region
| Japan |
Condition
Condition
Acute hypoxemic respiratory failure
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the persistence of respiratory physiological effects of HFNC (functional residual capacity increase and ventilation homogenization due to PEEP effect, and reduction of work of breathing due to dead space washout) in stable patients recovering from hypoxemic respiratory failure (clinically stable for more than 6 hours after HFNC weaning post-extubation), and to exploratorily identify clinical background factors of patients in whom these effects persist.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Global EELZ (End-Expiratory Lung Impedance): End-expiratory lung impedance measured by EIT, reflecting functional residual capacity and serving as a surrogate marker of PEEP effect by HFNC.
Key secondary outcomes
EIT measurements: Ventral EELZ, Dorsal EELZ, GI index, Ventral/Dorsal ventilation ratio, Global deltaZ, Ventral deltaZ, Dorsal deltaZ, Minute deltaZ
Esophageal pressure balloon measurements: Delta PES, PTP
Vital signs: Blood pressure, Respiratory rate, SpO2, Pulse rate, ROX index (SpO2/FiO2/RR)
Blood gas analysis: PaO2, PaCO2, pH, HCO3
Patient-reported outcomes: Comfort (NRS 0-10), Dyspnea (NRS 0-10)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
High-flow nasal cannula (HFNC) at 30 L/min for 30 minutes, followed by standard oxygen therapy via nasal cannula for 30 minutes. FiO2/flow adjusted to maintain SpO2 92-96%.
Interventions/Control_2
Standard oxygen therapy via nasal cannula for 30 minutes, followed by high-flow nasal cannula (HFNC) at 30 L/min for 30 minutes. FiO2/flow adjusted to maintain SpO2 92-96%.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with acute hypoxemic respiratory failure (P/F ratio <=300) during endotracheal intubation management in ICU
2. Patients who underwent PEEP adjustment with EIT during intubation management
3. Patients who had esophageal pressure tube inserted for transpulmonary pressure monitoring during intubation management
4. Patients who used HFNC after extubation
5. Patients who have been weaned from HFNC 30%/30L for 6-24 hours or more and have oxygen requirements
6. Patients who provided written informed consent for this study
Key exclusion criteria
1. Pregnant or breastfeeding
2. Age under 18 years
3. Consciousness disturbance
4. Pneumothorax findings on chest X-ray or CT
5. COPD GOLD stage IV
6. Contraindication to esophageal pressure measurement and/or EIT (electrical impedance tomography) monitoring
7. Patients with tracheostomy
8. End-of-life status or palliative care goals
9. Other patients judged inappropriate by the investigator
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Atsuhito |
| Middle name | |
| Last name | Inoue |
Organization
St. Marianna University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
+81-44-977-8111(ext3931)
atsuhito.inoue.2@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhito |
| Middle name | |
| Last name | Inoue |
Organization
St. Marianna University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
+81-44-977-8111(ext3931)
Homepage URL
atsuhito.inoue.2@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine, Department of Emergency and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine, Department of Emergency and Critical Care Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Bay Urayasu Ichikawa Medical Center, Department of Critical Care Medicine
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
IRB, St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
+81-44-977-8111
k-sienbu.mail@marianna-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
聖マリアンナ医科大学病院（神奈川県）、東京ベイ・浦安市川医療センター（千葉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 22 | Day |
Last modified on
| 2026 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070202
