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 2022/12/01 07:02:22

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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

Email

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


Email

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

Email

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


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

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

2022 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056469


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name