UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056735 |
|---|---|
| Receipt number | R000064840 |
| Scientific Title | Multicenter Prospective Observational Study on the Efficacy of High-Flow Nasal Cannula Oxygen Therapy for Multiple Rib Fractures in Older Adults |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/16 14:17:10 |
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Basic information
Public title
Multicenter Prospective Observational Study on the Efficacy of High-Flow Nasal Cannula Oxygen Therapy for Multiple Rib Fractures in Older Adults
Acronym
Respiratory Intervention Benefits for Rib fracturEs in older Adults Treated with High flow nasal cannula (RIBREATH) study
Scientific Title
Multicenter Prospective Observational Study on the Efficacy of High-Flow Nasal Cannula Oxygen Therapy for Multiple Rib Fractures in Older Adults
Scientific Title:Acronym
Respiratory Intervention Benefits for Rib fracturEs in older Adults Treated with High flow nasal cannula (RIBREATH) study
Region
| Japan |
Condition
Condition
multiple rib fracture
Classification by specialty
| Surgery in general | Orthopedics | Operative medicine |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to prospectively investigate the characteristics, treatments, and outcomes of older adults with multiple rib fractures. Specifically, it examines whether high-flow nasal cannula (HFNC) therapy as a respiratory support intervention can improve outcomes such as the incidence of pneumonia, mortality rates, ventilator use, length of hospital stay, duration of ICU stay, and severity of dyspnea.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence rate of hospital-acquired pneumonia
Key secondary outcomes
Proportion of deaths at discharge
30-day mortality rate after admission
Length of hospital stay
Ventilator use rate
Subjective evaluation of dyspnea
Length of ICU stay
Changes in the Clinical Frailty Scale
Incidence rate of adverse events, including those related to HFNC
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients meeting all of the following criteria will be included in the study:
1. Individuals with three or more rib fractures requiring hospitalization.
2. Individuals aged 65 years or older at the time of enrollment.
3. Individuals requiring oxygen therapy or presenting with a respiratory rate >20 breaths per minute at the time of admission.
Key exclusion criteria
Patients meeting any of the following criteria will be excluded from the study:
1. Individuals with contraindications to HFNC (e.g., severe facial fractures that prevent HFNC placement, basilar skull fractures, untreated pneumothorax, tracheal injuries, bronchial injuries, or esophageal injuries).
2. Individuals using NIPPV at the time of admission.
3. Individuals who are intubated at the time of admission.
4. Individuals whose survival is not expected to exceed 24 hours at the time of admission.
5. Individuals who refuse to participate in this study.
6. Individuals deemed unsuitable for participation in this study by the attending physician.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Morishita |
| Middle name | |
| Last name | Koji |
Organization
Institute of Science Tokyo
Division name
Department of Acute Critical Care and Disaster Medicine
Zip code
152-8550
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5102
morishita.accm@gmail.com
Public contact
Name of contact person
| 1st name | Hoshi |
| Middle name | |
| Last name | Hiromasa |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of Acute Critical Care Medicine
Zip code
300-0028
Address
4-1-1 Otsuno, Tsuchiura-shi, Ibaraki
TEL
029-830-3711
Homepage URL
adg3855@gmail.com
Sponsor or person
Institute
Department of Acute Critical Care and Disaster Medicine, Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Department of Acute Critical Care and Disaster Medicine, Institute of Science Tokyo
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
Life Science and Bioethics Research Center, Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4547
rinri.adm@tmd.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | 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
| 2025 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Type
This study is a multicenter prospective observational study led by the Japanese Association for Acute Medicine (JAAM), targeting acute care hospitals across Japan. The study will involve patients receiving treatment for multiple rib fractures as part of standard care, utilizing only information obtained within the scope of usual clinical practice.
Data Collection Items
If the patient has already been discharged at the time of data collection, follow-up will be conducted by phone to the subsequent location (e.g., transfer destination or home) to obtain as much information as possible. Data collection will not include information beyond 30 days after admission.
1. Patient Basic Information
2. Information on Multiple Rib Fractures
3. Mechanical Support Information
4. Procedures and Surgeries
5. Pain Management
6. Physical Therapy Information
7. Medication Information
Target Sample Size and Rationale
Target Sample Size: 1,000 cases
Study Period
Total duration: Approximately 5 years (April 1, 2025-March 31, 2030, planned)
Enrollment period: Approximately 3 years (April 1, 2025-March 31, 2028, planned)
Management information
Registered date
| 2025 | Year | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064840
