Using a new ventilation method for patients with severe lung issues
A Multicenter, Random Control Study: Early Use of Airway Pressure Release Ventilation Updated (APRVplus) Protocol in Acute Respiratory Disease Syndrome (ARDS)
This study is testing a new breathing method called APRVplus to see if it can help people with severe lung problems like Acute Respiratory Distress Syndrome feel better compared to the usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT03549910 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the early use of a specific ventilation technique called Airway Pressure Release Ventilation (APRVplus) in patients suffering from Acute Respiratory Distress Syndrome (ARDS). Participants will be randomly assigned to receive either the APRVplus protocol or conventional low tidal volume ventilation. The goal is to determine if APRVplus can improve lung function and patient outcomes compared to standard treatment. The study builds on previous findings that suggested potential benefits of APRV in ARDS management.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with moderate to severe ARDS who require mechanical ventilation.
Not a fit: Patients with conditions such as chronic obstructive pulmonary disease (COPD) or those expected to need mechanical ventilation for less than 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved lung function and recovery for patients with ARDS.
How similar studies have performed: Previous studies have shown potential benefits of APRV in ARDS, but this multicenter trial aims to provide more definitive evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chengdu, Sichuan
- West China Hospital,Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Yongfang Zhou
- Email: zyfmg@163.com
- Phone: 86 18140212276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.