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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044386
Receipt No. R000050647
Scientific Title Analysis of respiratory dynamics using 4D-CT during mechanical ventilation
Date of disclosure of the study information 2021/06/01
Last modified on 2021/06/01

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Basic information
Public title Analysis of respiratory dynamics using 4D-CT during mechanical ventilation
Acronym Analysis of respiratory dynamics using 4D-CT during mechanical ventilation
Scientific Title Analysis of respiratory dynamics using 4D-CT during mechanical ventilation
Scientific Title:Acronym Analysis of respiratory dynamics using 4D-CT during mechanical ventilation
Region
Japan

Condition
Condition Patients who required mechanical ventilation.
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Respiratory dynamics during ventilatory management (how each region of the lung moves depending on the state of breathing, whether alveoli are collapsed or overinflated, etc.) and safe ventilation settings are still unclear. We designed this study because 4D-CT (computed tomography with time axis) during ventilatory management is expected to improve patient prognosis by accurately assessing respiratory dynamics that have not been elucidated so far.
Basic objectives2 Others
Basic objectives -Others By performing a CT scan with a time axis (4D-CT), it is now possible to evaluate the respiratory dynamics in detail, including what kind of ventilation is applied to each lung region and the risk of lung injury. This test is expected to improve the prognosis by enabling appropriate respiratory management to minimize ventilation induced lung injury. In addition, it is possible to analyze the ventilation mechanics in the state where ventilation by ventilator and spontaneous breathing are mixed, which has not been clearly elucidated so far, and it is expected to analyze the effects of asynchrony.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of ventilation dynamics by lung regions.
Key secondary outcomes In this study, we will analyze the 4D-CT information in detail and validate the information obtained by this analysis according to several themes.
Evaluation of ventilation mechanics during asynchronies
Evaluation of optimal PEEP (positive end-expiratory pressure) and inspiratory pressure
Evaluation of optimal PEEP and inspiratory pressure
Incidence of ventilatory-related lung injury
Accuracy comparison with Electronic Impedance Tomography
The incidence of Pendelluft and evaluation of its dynamics and mechanism
Relevance of transpulmonary pressure information
Relationship between cardiac and pulmonary vascular circulatory dynamics and ventilation mechanics
Relevance of vascular permeability to ventilation mechanics
How the thorax and lungs move during ventilation
The relationship between vascular permeability and ventilation mechanics
Verification of respiratory dynamics before and after weaning from artificial respiration
The relationship between lung pathology and ventilation mechanics
Evaluation of the quality of spontaneous breathing and ventilation dynamics during forced ventilation

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 Patients requiring ventilatory management in the intensive care unit
Key exclusion criteria Patients under 18 years old
Patients who are expected to have difficulty in transportation and management during the CT scan
Target sample size 200

Research contact person
Name of lead principal investigator
1st name SHINSHU
Middle name
Last name KATAYAMA
Organization Department of Anesthesiology and Intensive Care Medicine, Jichi Medical University School of Medicine
Division name Division of Intensive Care
Zip code 329-0498
Address 3311-1, yakushiji, shimotsuke, Tochigi, Japan
TEL 0285-58-7392
Email shinsyu_k@jichi.ac.jp

Public contact
Name of contact person
1st name SHINSHU
Middle name
Last name KATAYAMA
Organization Department of Anesthesiology and Intensive Care Medicine,Jichi Medical University School of Medicine
Division name Division of Intensive Care
Zip code 329-0498
Address 3311-1, yakushiji, shimotsuke, Tochigi, Japan
TEL 0285-58-7392
Homepage URL
Email shinsyu_k@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization JSPS KAKENHI Grant Number 21K16594
Grant-in-Aid for Young Scientists
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 Department of Anesthesiology and Intensive Care Medicine, Jichi Medical University School of Medicine
Address 3311-1, yakushiji, shimotsuke, Tochigi, Japan
Tel 0285-58-7392
Email shinsyu_k@jichi.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
2021 Year 06 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 Enrolling by invitation
Date of protocol fixation
2020 Year 08 Month 06 Day
Date of IRB
2020 Year 08 Month 06 Day
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, 4D-CT will be performed at the time when chest CT is deemed necessary in the usual care. The patient will be moved to the CT room and managed with mechanical ventilation as in the usual care. Information such as EIT and esophageal pressure catheter will be collected before and after CT. All examinations and medical procedures, including 4D-CT, will be performed within the framework of usual care. The 4D-CT is already used in clinical practice in our hospital and is not invasive beyond the scope of usual care.

Management information
Registered date
2021 Year 06 Month 01 Day
Last modified on
2021 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050647

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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