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Completed

NCT Number: NCT06748807

Physiological Effects of APRVplus and TCAV in ARDS

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.

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Key information

Conditions

ARDS (Acute Respiratory Distress Syndrome) Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APRVplus

Procedure

Early Pathophysiology-driven Airway Pressure Release Ventilation (APRVplus)

TCAV

Procedure

Time-Controlled Adaptive Ventilation (TCAV)

Primary outcomes

  1. △PL（PLThigh - PLTlow)

    Time frame: during the mechanical ventilation procedure

    Transpulmonary pressure swings (△PL) equal to PLThigh - PLTlow

Secondary outcomes

  1. EtCO2

    Time frame: during the mechanical ventilation procedure

    end-tidal carbon dioxide

  2. GI

    Time frame: during the mechanical ventilation procedure

    global inhomogeneity

  3. PaO2(mmHg)

    Time frame: during the mechanical ventilation procedure

    the arterial partial pressure of oxygen

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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