UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059126 |
|---|---|
| Receipt number | R000066637 |
| Scientific Title | Effectiveness of High-Flow Nasal Cannula Oxygen Therapy in Adult Patients with Chest Trauma: A Systematic Review and Network Meta-analysis |
| Date of disclosure of the study information | 2025/09/18 |
| Last modified on | 2025/09/18 18:18:14 |
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Basic information
Public title
Effectiveness of High-Flow Nasal Cannula Oxygen Therapy in Adult Patients with Chest Trauma: A Systematic Review and Network Meta-analysis
Acronym
Effectiveness of High-Flow Nasal Cannula Oxygen Therapy in Adult Patients with Chest Trauma
Scientific Title
Effectiveness of High-Flow Nasal Cannula Oxygen Therapy in Adult Patients with Chest Trauma: A Systematic Review and Network Meta-analysis
Scientific Title:Acronym
Effectiveness of High-Flow Nasal Cannula Oxygen Therapy in Adult Patients with Chest Trauma: A Systematic Review and network Meta-analysis
Region
| Japan |
Condition
Condition
chest trauma
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although noninvasive positive pressure ventilation (NIV) has been shown to reduce intubation rates and complications compared to conventional oxygen therapy (COT) in patients with chest trauma, its use can be limited due to discomfort during application or contraindications such as facial injuries. High-flow nasal cannula (HFNC) therapy has attracted attention as an alternative that offers better tolerability and continuous oxygen delivery. In recent years, reports on the utility of HFNC have increased, but the conclusions remain inconsistent. This study aims to systematically review and evaluate the clinical effectiveness of HFNC therapy compared to COT and NIV in patients with chest trauma, with a particular focus on its potential to avoid endotracheal intubation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Escalation of respiratory support (modification of oxygen delivery method or transition to invasive mechanical ventilation)
Key secondary outcomes
Mortality within 28 days
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients with chest trauma requiring oxygen therapy will be included. A comprehensive literature search will be conducted to capture a broad range of relevant studies. The characteristics of the retrieved studies will then be examined to confirm the clinical and methodological coherence of the patient populations, and only eligible studies will be included in the network meta-analysis. Studies that do not meet the inclusion criteria but are considered relevant will not be incorporated into the network and will instead be reported narratively.
Key exclusion criteria
No exclusion criteria will be predefined. After the analysis, variability in exclusion criteria across the included studies will be described.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Taniguchi |
Organization
Japan Self Defense Forces Sapporo Hospital
Division name
Department of Emergency Medicine
Zip code
0050861
Address
17 Makomanai, Minami ward, Sapporo City, Hokkaido
TEL
81-01-581-3101
hiroaki.for.medical.journal@gmail.com
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Taniguchi |
Organization
Japan Self Defense Forces Sapporo Hospital
Division name
Department of Emergency Medicine
Zip code
0050861
Address
17 Makomanai, Minami ward, Sapporo City, Hokkaido
TEL
81-01-581-3101
Homepage URL
hiroaki.for.medical.journal@gmail.com
Sponsor or person
Institute
Japan Self Defense Forces Sapporo Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Defense Medical College
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Self Defense Forces Sapporo Hospital
Address
17 Makomanai, Minami ward, Sapporo City, Hokkaido, Japan
Tel
81-01-581-3101
hiroaki.for.medical.journal@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
| 2025 | Year | 09 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants: Adults with chest trauma requiring oxygen therapy. A comprehensive search will capture relevant studies, which will then be assessed for clinical and methodological coherence. Only eligible studies will be included in the network meta-analysis; others will be summarized narratively.
Interventions: High-flow nasal cannula (HFNC), conventional oxygen therapy (COT), and noninvasive ventilation (NIV).
Primary outcome: Escalation of respiratory support (change in oxygen therapy or intubation).
Study designs: Randomized controlled trials and observational studies with adequate statistical adjustment. Unadjusted observational studies, single-arm studies, case reports, abstracts, and protocols will be excluded.
Search strategy: PubMed, CENTRAL, CINAHL, ICTRP, ClinicalTrials.gov. Period: Jan 2000-Jun 2025. Language: English.
Data extraction and bias assessment: Two reviewers will extract data independently. Risk of bias will be assessed with Cochrane RoB 2 (RCTs) and ROBINS-I (observational studies).
Statistical analysis: Network meta-analysis will be conducted if data are sufficiently homogeneous. Dichotomous outcomes will be reported as risk ratios (95% CI), continuous outcomes as mean differences. Heterogeneity will be assessed using the I2 statistic.
Management information
Registered date
| 2025 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066637
