Physiological Effects of APRVplus and TCAV in ARDS

NCT ID: NCT06748807

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2024-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ARDS (Acute Respiratory Distress Syndrome)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

APRVplus

An Early Pathophysiology-driven Airway Pressure Release Ventilation

Group Type EXPERIMENTAL

APRVplus

Intervention Type PROCEDURE

Early Pathophysiology-driven Airway Pressure Release Ventilation (APRVplus)

TCAV

Time Controlled Adaptive Ventilation (TCAV)

Group Type OTHER

TCAV

Intervention Type PROCEDURE

Time-Controlled Adaptive Ventilation (TCAV)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

APRVplus

Early Pathophysiology-driven Airway Pressure Release Ventilation (APRVplus)

Intervention Type PROCEDURE

TCAV

Time-Controlled Adaptive Ventilation (TCAV)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

West China Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhou Yongfang

Zhou Yongfang

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023 approved No.193

Identifier Type: -

Identifier Source: org_study_id