A Multiple Centre,Random Control Study :Early Use of Airway Pressure Release Ventilation (APRV) Plus Protocol in ARDS

Study Overview
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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Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.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.

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

Official Title
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A Multiple Centre,Random Control Study :Early Use of Airway Pressure Release Ventilation Updated (APRV Plus) Protocol in Acute Respiratory Disease Syndrome (ARDS)

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Procedure: APRVplus protocol
* Procedure: Low tidal volume ventilation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early use of APRVplus protocol in ARDS<br>physiology-driven APRVplus protocol | Procedure: APRVplus protocol<br>* Physiology-driven APRVplus protocol<br>|
| Other: Low tidal volume ventilation<br>Low tidal volume lung protective ventilation | Procedure: Low tidal volume ventilation<br>* Low tidal volume lung protective ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | mortality at Day28 | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation free days | Mechanical ventilation free days at Day28 | Day 28 | 
| oxygenation | oxygenation index:PaO2:fiO2 | from enrollment to Day7 | 
| repiratory system compliance | static repiratory system compliance (ml/cmH2O) | from enrollment to Day7 | 
| MAP | mean arterial pressure | during the mechanical ventilation procedure | 
| sedation depth | RASS scores | during the mechanical ventilation procedure | 
| Sedative drug | the total dose of Sedative drug | during the mechanical ventilation procedure | 
| successful extubation rate | the rate of successful extubation | during the mechanical ventilation procedure |