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

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

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clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.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

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: APRVplus protocol; Procedure: Low tidal volume ventilation

Detailed Description

All the patients included will be randomly assigned to receiving APRV plus protocol or low tidal volume ventilation.

• Study Type: Interventional
• Enrollment (Estimated): 840
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yongfang Zhou; Phone Number: 86 18140212276; Email: zyfmg@163.com
• Study Contact Backup: Name: Yan Kang; Phone Number: 86 18980601566; Email: kang_yan_123@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital,Sichuan University
      • Contact: Yan Kang, MD; Phone Number: 86-18980601566; Email: kang_yan_123@163.com
      • Contact: Yongfang Zhou, MM; Phone Number: 86-18980606418; Email: zyfmg@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early use of APRVplus protocol in ARDS; physiology-driven APRVplus protocol	Procedure: APRVplus protocol; Physiology-driven APRVplus protocol
Other: Low tidal volume ventilation; Low tidal volume lung protective ventilation	Procedure: Low tidal volume ventilation; Low tidal volume lung protective ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	mortality at Day28	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical ventilation free days	Mechanical ventilation free days at Day28	Day 28
oxygenation	oxygenation index:PaO2:fiO2	from enrollment to Day7
repiratory system compliance	static repiratory system compliance (ml/cmH2O)	from enrollment to Day7
MAP	mean arterial pressure	during the mechanical ventilation procedure
sedation depth	RASS scores	during the mechanical ventilation procedure
Sedative drug	the total dose of Sedative drug	during the mechanical ventilation procedure
successful extubation rate	the rate of successful extubation	during the mechanical ventilation procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events related to mechanical ventilation	including pneumothorax,VAP,and so on	during the mechanical ventilation procedure

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Chair: Kang Yan, Department of Critical Care Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: Huaxi ICU-APRV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No