Airway Pressure Release Ventilation (APRV) Protocol Early Used in Acute Respiratory Distress Syndrome
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Device: Nellcor Puritan Bennett 840 ventilator system
- Registration Number
- NCT02639364
- Lead Sponsor
- West China Hospital
- 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 .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BILEVEL-APRV protocol Nellcor Puritan Bennett 840 ventilator system According to our BILEVEL-APRV protocol, BILEVEL-APRV APRV mode with specific settings,combination with spontaneous breathing. conventional ventilation strategy Nellcor Puritan Bennett 840 ventilator system The conventional ventilation strategy use volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) mode, combination with low tidal volume and adequate PEEP level.
- Primary Outcome Measures
Name Time Method Mechanical ventilation free days day 28
- Secondary Outcome Measures
Name Time Method tidal volume(ml) Day 7 peak airway pressure,mean airway pressure,positive end expiratory pressure(cmH2O) day 7 number of patients requiring the use of noninvasive ventilation Day 28 static lung compliance（ml/cmH2O） Day 7 Blood pressure(mmHg) Day 7 PaO2,PaCO2(mmHg) Day 7 Duration of hospital stay day 60 number of patients requiring cointerventions and Adjunctive Therapies Day 28 the tracheotomy rate Day 28 the number of days free from organ dysfunction Day 28 minute ventilation (L) Day 7 all causes mortality day 60 Participants will be followed for the duration of ICU stay
all cause hospital mortality day 60 Participants will be followed for the duration of hospital stay, until day 60 maximum.
Average dosage of vasoactive drugs each day in use day 7 Number of patients with a pneumothorax Day 28 blood lactic acid（mmol/l） Day 7 Richmond Sedation-Agitation Scale day 7 Duration of stay in ICU day 60 Average dosage of sedative infusion day 7
Trial Locations
- Locations (1)
Department of Critical care medicine of West China Hospital
🇨🇳Chengdu, Sichuan, China