Acute Respiratory Distress Syndrome
Conditions
Brief summary
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 .
Detailed description
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 .
Interventions
DEVICENellcor Puritan Bennett 840 ventilator system
Puritan Bennett 840 ventilator can provide the VCV,PCV,Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVER-APRV) mode.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Acute respiratory distress syndrome,according to the Berlin definition of ARDS, - The receipt of endotracheal mechanical ventilation for a period was no longer than 48 hours * A ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen(FiO2) was less than 250.
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) * Preexisting conditions with an expected 6-month mortality exceeding 50% * Pneumothorax (drained or not)at enrollment * Treatment with extracorporeal support (ECMO) at enrollment * There was a lack of commitment to life support.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mechanical ventilation free days | day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| all cause hospital mortality | day 60 | Participants will be followed for the duration of hospital stay, until day 60 maximum. |
| 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 | — |
| all causes mortality | day 60 | Participants will be followed for the duration of ICU stay |
| 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 | — |
| the tracheotomy rate | Day 28 | — |
Countries
China
Contacts
Primary ContactYongfang Zhou, master
Outcome results
None listed