Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients

Study Overview
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Brief Summary
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The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases. In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of death in patients. There is no unified treatment process for ARDS currently and the treatment measures are not yet standardized, so the standardization of ARDS treatment processes is needed to reduce mortality in patients. Following the evidence-based medicine principles and six-step treatment standards of ARDS, this study uses the method of multi-center randomized controlled clinical trials to evaluate the standardized treatment process of ARDS, which provides the basis for the standardized treatment of ARDS.

Detailed Description
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From September 1st 2012 to September 30th 2014, all ARDS patients admitted to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded.

Official Title
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Respiratory System Compliance Guided Tidal Volume in Moderate to Severe ARDS Patients: A Multicenter Randomized Controlled Study

Conditions
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Respiratory Failure, Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Behavioral: tidal volume guided by respiratory system compliance
* Behavioral: low tidal volume


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged ≥ 18 years admitted to the ICU according to the diagnostic criteria of ARDS Berlin definition，admit patients with severe ARDS Exclusion Criteria: age <18 years old be expected to die within 24 hours end-stage malignancies be participating in other studies, which may affect the results of this study DNI (do not intubation) and DNR (do not recovery) patients family members do not agree to sign an informed consent

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tidal volume guided by respiratory system compliance<br>effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS | Behavioral: tidal volume guided by respiratory system compliance<br>* ventilated with tidal volume guided by respiratory system compliance<br>|
| Experimental: low tidal volume<br>Ventilated patients with low tidal volume | Behavioral: low tidal volume<br>* ventilation ventilated with low tidal volume<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS |  | 28-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical Ventilation, ARDS, Ventilator Strategy, Outcome