UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049583 |
|---|---|
| Receipt number | R000056469 |
| Scientific Title | Analysis of ventilatory dynamics under two different positive end-expiratory pressure: a 4D-CT study |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2026/09/01 15:41:33 |
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Basic information
Public title
Analysis of ventilatory dynamics under two different positive end-expiratory pressure: a 4D-CT study
Acronym
Analysis of ventilatory dynamics under two different positive end-expiratory pressure: a 4D-CT study
Scientific Title
Analysis of ventilatory dynamics under two different positive end-expiratory pressure: a 4D-CT study
Scientific Title:Acronym
Analysis of ventilatory dynamics under two different positive end-expiratory pressure: a 4D-CT study
Region
| Japan |
Condition
Condition
acute respiratory distress syndrome
Classification by specialty
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine ventilation distribution in the lung field under two different positive end-expiratory pressure (PEEP), PEEP 5 cmH2O and PEEP 15 cmH2O, and analyze the prevalence of ventilator-induced lung injury (VILI) and lung-protective ventilation that minimizes VILI.
Basic objectives2
Others
Basic objectives -Others
Evaluation of ventilatory dynamics
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The main objectives of this study are to evaluate the following points in the lung areas among the different PEEP groups
1. the proportion and distribution of tidal recruitment in the alveoli
2. the proportion and distribution of over-inflation of the alveoli
3. proportion and distribution of alveolar inflation rate and movement
Key secondary outcomes
- Effect of different PEEPs on diaphragm and thorax shape changes
- Association of the 3 components of VILI with biomarkers of ARDS and mortality
- Correlation between EIT and 4D-CT analysis results (including regional ventilation delay)
- Comparison of the accuracy of the recallability endpoints (recruitment to inflation ratio, P-V loop, ventilator parameters such as transpulmonary pressure, EIT [electronical impedance tomography] as one of the imaging modalities, and pulmonary impedance tomography] and pulmonary ultrasonography)
- Comparison of changes in end-expiratory lung volume and the three components of VILI with and without recluitability
- Verification of the effect of PEEP on VILI, which is in conflict with recluitability
- Changes in ventilatory dynamics according to pathology and severity of disease
- Comparison of thoracic/lung elastance obtained by intraesophageal pressure with ventilatory dynamics
- Comparison of end-inspiratory and end-expiratory transpulmonary pressure information with ventilatory kinetics obtained by 4D-CT
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 with ARDS over 18 years of age requiring ventilatory management.
- The Berlin definition is used for defining ARDS.
- Patients are included if ventilatory management has been initiated within the first week.
Key exclusion criteria
- If pneumothorax or mediastinal emphysema is present
- If the patient has severe emphysema
- If the physician determines that the patient is at high risk of lung injury due to positive pressure
- Patients with severe asthma or acute exacerbations of COPD
- unstable hemodynamics or expected to be unstable hemodynamics (if stable under catecholamine administration, omit from the exclusion criteria)
- Significantly elevated cerebral pressure, if the physician determines that high PEEP should be avoided
- If a pacemaker or implantable cardioverter defibrillator is placed in the body
- Pregnant women
- Patient and family members are unable to give consent
- Other cases in which the physician deems it inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinshu |
| Middle name | |
| Last name | Katayama |
Organization
Jichi Medical University School of Medicine
Division name
Division of Intensive Care, Department of Anesthesiology and Intensive Care Medicine,
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan
TEL
0285-58-7392
shinsyu_k@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Shinshu |
| Middle name | |
| Last name | Katayama |
Organization
Jichi Medical University School of Medicine
Division name
Division of Intensive Care, Department of Anesthesiology and Intensive Care Medicine,
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan
TEL
0285-58-7392
Homepage URL
shinsyu_k@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
internal fund
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Clinical Research Center, Jichi Medical University Hospital
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan
Tel
0285-58-8933
rinri@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
| 2022 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://academic.oup.com/ajrccm/article-abstract/212/6/1253/8532517
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/ajrccm/article-abstract/212/6/1253/8532517
Number of participants that the trial has enrolled
40
Results
Forty patients with stabilized ARDS underwent 4D-CT before and after PEEP reduction from 15 to 5 cmH2O. Tidal recruitment increased only slightly from 1.15% to 1.84% (P<0.001). End-inspiratory over-inflation decreased from 11.9% to 5.2%, and tidal over-inflation from 42.5% to 18.3% (both P<0.001). EELV decreased by 787 mL, exceeding the change predicted by passive elastic deflation and indicating substantial alveolar derecruitment.
Results date posted
| 2026 | Year | 09 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 40 patients with stabilized ARDS. Median age was 63 years [IQR 52-72], and 27 patients (67.5%) were male. The median APACHE II score was 19 [14-26]. Pulmonary ARDS was present in 29 patients (72.5%), extrapulmonary ARDS in 11 patients (27.5%), and COVID-19 ARDS in 12 patients (30.0%). At the time of 4D-CT, the median PaO2/FIO2 ratio was 203 [159-233], and 31 patients (77.5%) had a ratio of 150 or higher. The median clinical PEEP before the study protocol was 8 [6-10] cmH2O.
Participant flow
Forty eligible patients with ARDS were enrolled after written informed consent was obtained from the patient or a legally authorized representative. All 40 patients underwent assessment according to the study protocol and were included in the primary outcome analysis. There were no missing data for the primary outcome.
Adverse events
No adverse events related to the study protocol occurred.
Outcome measures
[Primary Outcome]
Whole-lung tidal recruitment
Tidal recruitment was defined on 4D-CT as lung tissue with CT attenuation from -200 to +100 HU at end-expiration that became aerated at end-inspiration, expressed as a percentage of expiratory tissue weight. The primary outcome was the change in whole-lung tidal recruitment between PEEP 15 and 5 cmH2O.
[Secondary Outcomes]
1. Over-inflation
Over-inflation was defined as CT attenuation from -1000 to -901 HU. End-inspiratory, end-expiratory, and tidal over-inflation were assessed.
2. Lung volumes
EELV and EILV were measured by 4D-CT. EELV change was compared with passive elastic deflation predicted from respiratory system compliance to estimate alveolar derecruitment.
3. Regional analysis
Tidal recruitment and over-inflation were assessed across six lung regions.
[Exploratory Outcome]
Effect modification by the recruitment-to-inflation ratio was explored.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | 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
No special remarks
Management information
Registered date
| 2022 | Year | 11 | Month | 22 | Day |
Last modified on
| 2026 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056469
