Clinical trial NCT03549910: A Multicenter, Random Control Study :Early Use of Airway Pressure Release Ventilation (APRVplus) Protocol in ARDS
Official title: A Multicenter, Random Control Study: Early Use of Airway Pressure Release Ventilation Updated (APRVplus) Protocol in Acute Respiratory Disease Syndrome (ARDS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 840
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: SUPPORTIVE_CARE

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Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.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.

Eligibility 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:

* 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.

Primary outcomes:
measure: mortality
timeFrame: Day 28
Secondary outcomes:
measure: Mechanical ventilation free days
timeFrame: Day 28
measure: oxygenation
timeFrame: from enrollment to Day7
measure: repiratory system compliance
timeFrame: from enrollment to Day7
measure: MAP
timeFrame: during the mechanical ventilation procedure
measure: sedation depth
timeFrame: during the mechanical ventilation procedure
measure: Sedative drug
timeFrame: during the mechanical ventilation procedure
measure: successful extubation rate
timeFrame: during the mechanical ventilation procedure
Other outcomes:
measure: adverse events related to mechanical ventilation
timeFrame: during the mechanical ventilation procedure
Locations:
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
state: Sichuan
Study officials:
affiliation: Department of Critical Care Medicine
name: Kang Yan
role: STUDY_CHAIR
References: