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Analysis of ventilatory dynamics under two different positive end-expiratory pressure: a 4D-CT study

Analysis of ventilatory dynamics under two different positive end-expiratory pressure: a 4D-CT study - Analysis of ventilatory dynamics under two different positive end-expiratory pressure: a 4D-CT study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000049583
Enrollment
40
Registered
2022-12-01
Start date
2022-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute respiratory distress syndrome

Interventions

None listed

Sponsors

Jichi Medical University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
- 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

Countries

Japan

Contacts

Public ContactShinshu Katayama

Jichi Medical University School of Medicine Division of Intensive Care, Department of Anesthesiology and Intensive Care Medicine,

shinsyu_k@jichi.ac.jp0285-58-7392

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026