UMIN-CTR Clinical Trial

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 03 Month 03 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