Acute Respiratory Distress Syndrome
Conditions
Brief summary
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Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.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
All the patients included will be randomly assigned to receiving APRV plus protocol or low tidal volume ventilation.
Interventions
PROCEDUREAPRVplus protocol
Physiology-driven APRVplus protocol
PROCEDURELow tidal volume ventilation
Low tidal volume lung protective ventilation
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mortality | Day 28 | mortality at Day28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical ventilation free days | Day 28 | Mechanical ventilation free days at Day28 |
| oxygenation | from enrollment to Day7 | oxygenation index:PaO2:fiO2 |
| repiratory system compliance | from enrollment to Day7 | static repiratory system compliance (ml/cmH2O) |
| sedation depth | during the mechanical ventilation procedure | RASS scores |
| Sedative drug | during the mechanical ventilation procedure | the total dose of Sedative drug |
| successful extubation rate | during the mechanical ventilation procedure | the rate of successful extubation |
| MAP | during the mechanical ventilation procedure | mean arterial pressure |
Other
| Measure | Time frame | Description |
|---|---|---|
| adverse events related to mechanical ventilation | during the mechanical ventilation procedure | including pneumothorax,VAP,and so on |
Countries
China
Contacts
Primary ContactYongfang Zhou
Backup ContactYan Kang
Outcome results
None listed