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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06748807

Enrollment

Registered

2024-12-27

Start date

2023-12-15

Completion date

2024-12-15

Last updated

2024-12-27

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

Conditions

ARDS (Acute Respiratory Distress Syndrome)

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.

Interventions

PROCEDUREAPRVplus

Early Pathophysiology-driven Airway Pressure Release Ventilation (APRVplus)

PROCEDURETCAV

Time-Controlled Adaptive Ventilation (TCAV)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* intubated and mechanically ventilated patients * meet the 2023 global new definition of ARDS

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
△PL（PLThigh - PLTlow)	during the mechanical ventilation procedure	Transpulmonary pressure swings (△PL) equal to PLThigh - PLTlow

Secondary

Measure	Time frame	Description
EtCO2	during the mechanical ventilation procedure	end-tidal carbon dioxide
GI	during the mechanical ventilation procedure	global inhomogeneity
PaO2(mmHg)	during the mechanical ventilation procedure	the arterial partial pressure of oxygen

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026