A Multicenter, Random Control Study :Early Use of Airway Pressure Release Ventilation (APRVplus) Protocol in ARDS

Not Applicable

Recruiting

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Procedure: Low tidal volume ventilation; Procedure: APRVplus protocol

• Registration Number: NCT03549910
• Lead Sponsor: West China Hospital

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clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.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

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-08
• Study Start: 2020-12-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 840

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low tidal volume ventilation	Low tidal volume ventilation	Low tidal volume lung protective ventilation
Early use of APRVplus protocol in ARDS	APRVplus protocol	physiology-driven APRVplus protocol

Primary Outcome Measures

Name	Time	Method
mortality	Day 28	mortality at Day28

Secondary Outcome Measures

Name	Time	Method
oxygenation	from enrollment to Day7	oxygenation index:PaO2:fiO2
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
Mechanical ventilation free days	Day 28	Mechanical ventilation free days at Day28
MAP	during the mechanical ventilation procedure	mean arterial pressure
repiratory system compliance	from enrollment to Day7	static repiratory system compliance (ml/cmH2O)
sedation depth	during the mechanical ventilation procedure	RASS scores

Trial Locations

Locations (1)

West China Hospital,Sichuan University; 🇨🇳 Chengdu, Sichuan, China