Physiological Effects of Lung Impedance Tomography-Guided and Plat Pressure-Guided Phigh During APRV in Patients With ARDS
1 other identifier
interventional
26
1 country
1
Brief Summary
This study aims to investigate the effects of EIT-guided and Pplat-guided Phigh settings on regional ventilation and perfusion in ARDS patients during APRV, while also examining the impact of different Phigh settings on gas exchange, respiratory mechanics, and hemodynamics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2024
CompletedFirst Posted
Study publicly available on registry
November 20, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 6, 2025
January 1, 2025
2 years
November 13, 2024
January 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effects of Phigh guided by different methods on regional lung ventilation assessed by EIT
1 Hour Post-Intervention
Secondary Outcomes (5)
Global inhomogeneity assessed by electrical impedance tomography
1 Hour Post-Intervention
Center of ventilation assessed by electrical impedance tomography
1 Hour Post-Intervention
ventilation/perfusion matching assessed by EIT
1 Hour Post-Intervention
Respiratory system compliance
1 Hour Post-Intervention
mean arterial pressure
1 Hour Post-Intervention
Study Arms (2)
Intervention group
EXPERIMENTALEIT-guided Phigh settings during APRV
Control group
NO INTERVENTIONPplat-guided Phigh settings during APRV
Interventions
The Phigh level selected for the patients in the Intervention group was the intercept point of cumulated collapse and overdistension percentage curves, providing the best compromise between collapsed and overdistended lung.
Eligibility Criteria
You may qualify if:
- Diagnosed with ARDS according to the 2023 global new definition of ARDS.
- Age ≥ 18 years.
You may not qualify if:
- Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bullae, pneumothorax, subcutaneous emphysema, mediastinal emphysema, etc. · Contraindications for EIT, such as chest wound dressing, pacemaker implantation, defibrillator use, etc.
- Pulmonary interstitial disease.
- Uncorrected shock of various types.
- Intracranial hypertension.
- Pregnant and postpartum women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wuhan Union hospital
Wuhan, Hubei, 237000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
November 13, 2024
First Posted
November 20, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 6, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share