UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050024 |
|---|---|
| Receipt number | R000054412 |
| Scientific Title | Development and validation of prediction models for treatment failure of HFNC in COVID-19: a multicenter cohort study |
| Date of disclosure of the study information | 2023/01/13 |
| Last modified on | 2023/01/13 10:03:12 |
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Basic information
Public title
Development and validation of prediction models for treatment failure of HFNC in COVID-19: a multicenter cohort study
Acronym
Development and validation of prediction models for treatment failure of HFNC in COVID-19: a multicenter cohort study
Scientific Title
Development and validation of prediction models for treatment failure of HFNC in COVID-19: a multicenter cohort study
Scientific Title:Acronym
Development and validation of prediction models for treatment failure of HFNC in COVID-19: a multicenter cohort study
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate and compare the predictive performance of the ROX score and HACOR score for patients with COVID-19 pneumonia using HFNT.
To develop and validate a new model to predict outcomes for COVID-19 pneumonia patients using HFNT
Basic objectives2
Others
Basic objectives -Others
Predictive performance
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Failure of treatment (intubation or death within 1 week, transition to noninvasive positive pressure ventilation)
Key secondary outcomes
Death within 1 week, intubation within 1 week, transition to noninvasive positive pressure ventilation, and
Clinicallyy important intubation
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
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients 18 years of age or older with confirmed positive SARS-Cov2 (RT-PCR SARS-Cov2, LAMP method, antigen test) who were hospitalized and treated with HFNT.
(2) No more criteria for starting HFNT.
Key exclusion criteria
Patients under 18 years of age
Patients who used non-invasive positive pressure ventilation (NIV) prior to the use of HFNT
Patients with Do not Intubation
Use after extubation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Konno |
Organization
Tohoku University Hospital
Division name
Department of Anesthesiology
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7321
konnodaisuke@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Irimada |
Organization
Graduate School of Medicine, Tohoku University
Division name
Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7321
Homepage URL
daisukeirimada78@yahoo.ne.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Irimada Diasuke
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
JCEPTIC-CTG
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
東北大学（宮城県）、名古屋大学病院(愛知）、自治医科大学付属さいたま医療センター
亀田総合病院（千葉）、高知医療センター（高知）、防衛医科大学校病院（埼玉）、
東京都立広尾病院（東京）、佐賀大学病院（佐賀）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 13 | 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
300
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 30 | Day |
Other
Other related information
(1) Outline of Study Methods
The study will include patients who are at least 18 years of age and who were hospitalized with COVID-19 pneumonia and treated with HFNT. Subjects will be divided into those managed with HFNT who successfully weaned from HFNT and those who were ultimately intubated. cutoff values for treatment success in ROX score and HACOR score in patients with HFNT will be calculated.
(2) Study design
This is a multicenter, retrospective, observational study, and patients with COVID-19 pneumonia who were admitted and underwent HFNT between January 16, 2020 and March 31, 2022 will be selected from electronic records.
(3) Evaluation Items and Methods
The following will be collected
Treatment failure (intubation or death within 1 week, conversion to noninvasive positive pressure ventilation), death within 1 week, intubation within 1 week, conversion to noninvasive positive pressure ventilation, clinically important intubation, basic patient information (age, sex, height, weight, start and end date and time of HFNT (if reattached, data from initial use should be included), vaccinations, presence of comorbidities (hypertension, chronic obstructive pulmonary disease, cancer carriage, heart failure, dementia), vital signs, blood gas data, etc.
For more information on the research plan, please visit
https://www.dropbox.com/s/q9yo6s6kuvablzl/%E7%A0%94%E7%A9%B6%E8%A8%88%E7%94%BB%E6%9B%B8%20%E7%AC%AC1%E7%89%88.pdf?dl=0
Management information
Registered date
| 2023 | Year | 01 | Month | 13 | Day |
Last modified on
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054412
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
