UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053876 |
|---|---|
| Receipt number | R000061448 |
| Scientific Title | Investigating the risk of ventilator-induced lung injury in patients with acute respiratory distress syndrome using lung stress mapping: multicenter prospective observational study |
| Date of disclosure of the study information | 2024/03/15 |
| Last modified on | 2024/03/15 19:06:59 |
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Basic information
Public title
Investigating the risk of ventilator-induced lung injury in patients with acute respiratory distress syndrome using lung stress mapping: multicenter prospective observational study
Acronym
Investigating the risk of ventilator-induced lung injury in patients with ARDS using lung stress mapping
Scientific Title
Investigating the risk of ventilator-induced lung injury in patients with acute respiratory distress syndrome using lung stress mapping: multicenter prospective observational study
Scientific Title:Acronym
Investigating the risk of ventilator-induced lung injury in patients with ARDS using lung stress mapping
Region
| Japan |
Condition
Condition
ARDS
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
ARDS is an acute respiratory failure characterized by noncardiogenic pulmonary edema, for which ventilatory management is essential for survival. A lung-protective ventilation strategy based on tidal volume limitation is recommended to prevent ventilator-associated lung injury due to alveolar hyperextension. However, uniform ventilatory management using the same tidal volume for all ARDS patients has resulted in a high in-hospital mortality rate of approximately 40%. Therefore, there is an urgent need to establish "personalized" ventilation strategies according to the risk of ventilator-induced lung injury. Although the measurement of transpulmonary pressure using an esophageal balloon is a clinical technique that can assess the risk of ventilator-induced lung injury, it only reflects a specific local lung area and does not provide a detailed and accurate assessment of the risk of lung injury in the entire lung. Therefore, we developed a technique to visualize transpulmonary pressure in the entire lung region by fusing esophageal pressure data with lung CT image data. The objectives of this study were to clarify Lung stress mapping in adult ARDS patients to examine whether there is a relationship between Lung stress mapping and prognosis and to generate a risk prediction model for ventilator-induced lung injury based on Lung stress mapping using artificial brain technology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify Lung stress mapping and to determine the association between the amount of high Lung stress areas in the lungs and ventilator-free days.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients over 18 years of age
2) ARDS patients requiring ventilatory management
(The Berlin definition is used for the diagnosis of ARDS)
3) Patients who are scheduled for or have undergone chest CT imaging as part of diagnosis and treatment.
(CT scan of the chest should be performed within 5 days of meeting the criteria for the diagnosis of ARDS.)
Key exclusion criteria
1) Patients with esophageal diseases (post-esophageal surgery, active bleeding, etc.) that make esophageal intra-esophageal pressure measurement impossible.
2) Patients with do-not-resuscitate (DNR)
3) Patients on home ventilator management
4) Patients with a ventricular assist device (VAD) or a venous-arterial extracorporeal membrane ventricular pump (VA-ECMO) for heart failure
5) Patients with a history of neuromuscular disease
6) Pregnant women
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoshida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
08051634223
t.hoshino.mie@gmail.com
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Hoshino |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
+81-6-6879-5820
Homepage URL
https://www.med.osaka-u.ac.jp/pub/anes/intensive_care3.html
t.hoshino.mie@gmail.com
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board Osaka University Hospital
Address
Advanced Medical Innovation Center Building, 2-2 Yamadaoka, Suita City, Osaka, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061448
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