Physiological Effects of APRVplus and TCAV in ARDS
Physiological Effects of Early Pathophysiology-driven Airway Pressure Release Ventilation (APRVplus) and Time-Controlled Adaptive Ventilation (TCAV) in Acute Respiratory Distress Syndrome (ARDS): a Randomized Crossover Clinical Trial
1 other identifier
interventional
20
1 country
1
Brief Summary
In previous studies, airway pressure release ventilation (APRV) has been proven to be an important respiratory support method for ARDS patients, and various APRV ventilation strategies have been proposed. This study aims to compare the physiological effects of two types of APRV ventilation strategy, Early Pathophysiology-driven APRV (APRVplus) and Time-Controlled Adaptive Ventilation (TCAV), through randomized crossover trials, providing evidence for clinical application and further research on APRV.
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 Dec 2023
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
Study Start
First participant enrolled
December 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedFirst Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
December 27, 2024
CompletedDecember 27, 2024
December 1, 2024
1 year
December 19, 2024
December 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
△PL（PLThigh - PLTlow)
Transpulmonary pressure swings (△PL) equal to PLThigh - PLTlow
during the mechanical ventilation procedure
Secondary Outcomes (3)
EtCO2
during the mechanical ventilation procedure
GI
during the mechanical ventilation procedure
PaO2(mmHg)
during the mechanical ventilation procedure
Study Arms (2)
APRVplus
EXPERIMENTALAn Early Pathophysiology-driven Airway Pressure Release Ventilation
TCAV
OTHERTime Controlled Adaptive Ventilation (TCAV)
Interventions
Eligibility Criteria
You may qualify if:
- intubated and mechanically ventilated patients
- meet the 2023 global new definition of ARDS
You may not qualify if:
- Pregnancy
- The expected duration of mechanical ventilation was less than 48 hours
- Intracranial hypertension (suspected or confirmed)
- Neuromuscular disorders that are known to prolong the need for mechanical ventilation
- Known or suspected chronic obstructive pulmonary disease(COPD)
- Terminal stage of disease
- Pneumothorax (drained or not)at enrollment
- Treatment with extracorporeal support (ECMO) at enrollment
- There was a lack of commitment to life support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Zhou Yongfang
Study Record Dates
First Submitted
December 19, 2024
First Posted
December 27, 2024
Study Start
December 15, 2023
Primary Completion
December 15, 2024
Study Completion
December 15, 2024
Last Updated
December 27, 2024
Record last verified: 2024-12