A Multicenter, Random Control Study :Early Use of Airway Pressure Release Ventilation (APRVplus) Protocol in ARDS

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2024-12-30

Brief Summary

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Animal experimentals have shown that the more physiology-driven airway pressure release ventilation (APRV) methodologies in ARDS may significantly improve alveolar recruitment and gas exchange, increased homogeneity, and attenuate lung injury, without circulatory depression, as compared with conventional low tial volume lung protective ventilation. our previous single centre,random control study showed that clinical benefit for early use of APRV in ARDS. Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.

Additionally, the previous single-centre,random control study showed that clinical benefit for APRV.Therefore,the investigators are ready to design a multiple centres,random control study to further verify the effect of APRV plus protocol in ARDS.

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Detailed Description

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All the patients included will be randomly assigned to receiving APRV plus protocol or low tidal volume ventilation.

Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Early use of APRVplus protocol in ARDS

physiology-driven APRVplus protocol

Group Type EXPERIMENTAL

APRVplus protocol

Intervention Type PROCEDURE

Physiology-driven APRVplus protocol

Low tidal volume ventilation

Low tidal volume lung protective ventilation

Group Type OTHER

Low tidal volume ventilation

Intervention Type PROCEDURE

Low tidal volume lung protective ventilation

Interventions

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APRVplus protocol

Physiology-driven APRVplus protocol

Intervention Type PROCEDURE

Low tidal volume ventilation

Low tidal volume lung protective ventilation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Moderate and severe acute respiratory distress syndrome,according to the Berlin definition of ARDS
* receiving tracheal intubation and mechanical ventilation was no longer than 48 hours

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

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No