Using a new ventilation method for patients with severe lung injury
Early Use of Airway Pressure Release Ventilation (APRV) in Patients With Acute Respiratory Distress Syndrome
This study is testing a new breathing method for patients with severe lung injury to see if it helps them breathe better and need less medication compared to standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Civil de Guadalajara Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guadalajara, Jalisco) |
| Trial ID | NCT04221737 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the early use of Airway Pressure Release Ventilation (APRV) compared to conventional mechanical ventilation in patients suffering from Acute Respiratory Distress Syndrome (ARDS). The study aims to determine the effects and safety of APRV, which allows for spontaneous breathing and improved gas exchange, in a multi-center, randomized, controlled setting. By focusing on patients who have been on mechanical ventilation for less than 48 hours, the trial seeks to assess whether this innovative approach can enhance oxygenation and reduce the need for sedation and neuromuscular blockers. The ultimate goal is to improve patient outcomes and reduce mortality associated with ARDS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with ARDS who have been on mechanical ventilation for less than 48 hours.
Not a fit: Patients with preexisting conditions that predict a high mortality risk or those requiring very short-term mechanical ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve oxygenation and reduce mortality rates in patients with ARDS.
How similar studies have performed: While APRV is considered a non-conventional ventilatory mode, its effectiveness compared to standard methods in ARDS patients is still being explored, indicating a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute respiratory distress syndrome, according to the Berlin definition of ARDS, with adjusted pO2/FiO2 for altitude \<300, and less than 48 h of endotracheal mechanical ventilation Exclusion Criteria: * Pregnancy * Less than 18 years-old * Expected duration of mechanical ventilation less than 48 h * Preexisting conditions with an expected 3-month mortality exceeding 50% * Concurrent chemotherapy * Confirmed intracranial hypertension * Catastrophic cranial trauma or neuromuscular disorders that are known to prolong mechanical ventilation * Pneumothorax at enrollment (resolved or not) * Do-not-resuscitate order
Where this trial is running
Guadalajara, Jalisco
- Hospital Civil Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico (Recruiting)
Study contacts
- Principal investigator: Miguel Ibarra-Estrada, Dr — Hospital Civil Fray Antonio Alcalde
- Study coordinator: Miguel Ibarra-Estrada, Dr
- Email: drmiguelibarra@hotmail.com
- Phone: 3317593502
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.