Clinical trial NCT02639364: Airway Pressure Release Ventilation (APRV) Protocol Early Used in Acute Respiratory Distress Syndrome
Official title: the Effects and Safety of the Early Application of Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVEL-APRV) Protocol and Conventional Ventilation Strategy Were Compared in ARDS Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2015-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Mechanical ventilation free days
timeFrame: day 28
Secondary outcomes:
measure: all causes mortality
timeFrame: day 60
measure: all cause hospital mortality
timeFrame: day 60
measure: Duration of stay in ICU
timeFrame: day 60
measure: Duration of hospital stay
timeFrame: day 60
measure: peak airway pressure,mean airway pressure,positive end expiratory pressure(cmH2O)
timeFrame: day 7
measure: Average dosage of sedative infusion
timeFrame: day 7
measure: Richmond Sedation-Agitation Scale
timeFrame: day 7
measure: Average dosage of vasoactive drugs each day in use
timeFrame: day 7
measure: number of patients requiring cointerventions and Adjunctive Therapies
timeFrame: Day 28
measure: number of patients requiring the use of noninvasive ventilation
timeFrame: Day 28
measure: the tracheotomy rate
timeFrame: Day 28
measure: Number of patients with a pneumothorax
timeFrame: Day 28
measure: the number of days free from organ dysfunction
timeFrame: Day 28
measure: tidal volume(ml)
timeFrame: Day 7
measure: static lung compliance（ml/cmH2O）
timeFrame: Day 7
measure: PaO2,PaCO2(mmHg)
timeFrame: Day 7
measure: Blood pressure(mmHg)
timeFrame: Day 7
measure: blood lactic acid（mmol/l）
timeFrame: Day 7
measure: minute ventilation (L)
timeFrame: Day 7
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Department of Critical care medicine of West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Yan Kang, doctor
role: STUDY_DIRECTOR
References: