A Multiple Centre,Random Control Study :Early Use of Airway Pressure Release Ventilation (APRV) Plus Protocol in ARDS
Study Details
Study Description
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Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
All the patients included will be randomly assigned to receiving APRV plus protocol or low tidal volume ventilation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Early use of APRVplus protocol in ARDS physiology-driven APRVplus protocol |
Procedure: APRVplus protocol
Physiology-driven APRVplus protocol
|
| Other: Low tidal volume ventilation Low tidal volume lung protective ventilation |
Procedure: Low tidal volume ventilation
Low tidal volume lung protective ventilation
|
Outcome Measures
Primary Outcome Measures
- mortality [Day 28]
mortality at Day28
Secondary Outcome Measures
- 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)
- MAP [during the mechanical ventilation procedure]
mean arterial pressure
- 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
Other Outcome Measures
- adverse events related to mechanical ventilation [during the mechanical ventilation procedure]
including pneumothorax,VAP,and so on
Eligibility Criteria
Criteria
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:
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- West China Hospital
Investigators
- Study Chair: Kang Yan, Department of Critical Care Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Huaxi ICU-APRV