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The aim of this study is to assess the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .
Although mechanical ventilation is life-sustaining for patients with ARDS, it can perpetuate lung injury. A number of recent advances have greatly improved in the mechanical ventilation strategies and treatment for acute respiratory distress syndrome (ARDS), however, Mortality remains high, even with the use of low tidal volume and adequate positive end expiratory pressure(PEEP). Numerous experimental showed that the BILEVEL-APRV mode used in animal ARDS model can improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the dosage for sedative drugs.
The aim of this single-center, prospective, randomized, controlled, open study is to compare the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional ventilation strategy | Active Comparator | The conventional ventilation strategy use volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) mode, combination with low tidal volume and adequate PEEP level. |
|
| BILEVEL-APRV protocol | Experimental | According to our BILEVEL-APRV protocol, BILEVEL-APRV APRV mode with specific settings,combination with spontaneous breathing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nellcor Puritan Bennett 840 ventilator system | Device | Puritan Bennett 840 ventilator can provide the VCV,PCV,Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVER-APRV) mode. |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical ventilation free days | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| all causes mortality | Participants will be followed for the duration of ICU stay | day 60 |
| all cause hospital mortality | Participants will be followed for the duration of hospital stay, until day 60 maximum. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongfang Zhou, master | Contact | 8618140212276 | zyfmg@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Kang, doctor | West China Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Critical care medicine of West China Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| day 60 |
| Duration of stay in ICU | day 60 |
| Duration of hospital stay | day 60 |
| peak airway pressure,mean airway pressure,positive end expiratory pressure(cmH2O) | day 7 |
| Average dosage of sedative infusion | day 7 |
| Richmond Sedation-Agitation Scale | day 7 |
| Average dosage of vasoactive drugs each day in use | day 7 |
| number of patients requiring cointerventions and Adjunctive Therapies | Day 28 |
| number of patients requiring the use of noninvasive ventilation | Day 28 |
| the tracheotomy rate | Day 28 |
| Number of patients with a pneumothorax | Day 28 |
| the number of days free from organ dysfunction | Day 28 |
| tidal volume(ml) | Day 7 |
| static lung compliance(ml/cmH2O) | Day 7 |
| PaO2,PaCO2(mmHg) | Day 7 |
| Blood pressure(mmHg) | Day 7 |
| blood lactic acid(mmol/l) | Day 7 |
| minute ventilation (L) | Day 7 |