Airway Pressure Release Ventilation (APRV) Protocol Early Used in Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02639364
• Other study ID #: 2015 approval (156)
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2015
• Last updated: December 24, 2015
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: West China Hospital
• Contact: Yongfang Zhou, master
• Phone: 8618140212276
• Email: zyfmg[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 .

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Nellcor Puritan Bennett 840 ventilator system
Puritan Bennett 840 ventilator can provide the VCV,PCV,Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVER-APRV) mode.

Locations

Country	Name	City	State
China	Department of Critical care medicine of West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical ventilation free days		day 28	Yes
Secondary	all causes mortality	Participants will be followed for the duration of ICU stay	day 60	Yes
Secondary	all cause hospital mortality	Participants will be followed for the duration of hospital stay, until day 60 maximum.	day 60	Yes
Secondary	Duration of stay in ICU		day 60	No
Secondary	Duration of hospital stay		day 60	No
Secondary	peak airway pressure,mean airway pressure,positive end expiratory pressure(cmH2O)		day 7	No
Secondary	Average dosage of sedative infusion		day 7	No
Secondary	Richmond Sedation-Agitation Scale		day 7	No
Secondary	Average dosage of vasoactive drugs each day in use		day 7	No
Secondary	number of patients requiring cointerventions and Adjunctive Therapies		Day 28	No
Secondary	number of patients requiring the use of noninvasive ventilation		Day 28	Yes
Secondary	the tracheotomy rate		Day 28	Yes
Secondary	Number of patients with a pneumothorax		Day 28	Yes
Secondary	the number of days free from organ dysfunction		Day 28	Yes
Secondary	tidal volume(ml)		Day 7	No
Secondary	static lung compliance(ml/cmH2O)		Day 7	No
Secondary	PaO2,PaCO2(mmHg)		Day 7	No
Secondary	Blood pressure(mmHg)		Day 7	No
Secondary	blood lactic acid(mmol/l)		Day 7	No
Secondary	minute ventilation (L)		Day 7	No