Effect of low tidal volume and prone positioning in patients with severe lung injury
Physiological Effect of Prone Position in Patients With Ultra-low Tidal Volume Ventilation
This study is testing if using very low tidal volume ventilation and having patients lie on their stomach can help adults with severe lung injury breathe better and recover faster while on a special breathing machine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Southeast University, China Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06215209 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of using ultra-low tidal volume ventilation in patients with acute respiratory distress syndrome (ARDS) who are supported by venovenous extracorporeal membrane oxygenation (VV-ECMO). The study aims to determine if adjusting tidal volume to less than 6 ml/kg can reduce ventilator-induced lung injury and improve clinical outcomes. Additionally, the study evaluates the impact of prone positioning on ventilation-perfusion matching and hemodynamics in these patients. The research focuses on adult patients undergoing invasive mechanical ventilation for less than 48 hours.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing invasive mechanical ventilation and supported by VV-ECMO for less than 48 hours.
Not a fit: Patients younger than 18 years old or those with contraindications for prone position ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes and reduced lung injury in patients with severe ARDS.
How similar studies have performed: Other studies have shown promising results with low tidal volume strategies and prone positioning in ARDS, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients were enrolled if they were undergoing invasive mechanical ventilation and were supported by VV-ECMO for less than 48 hours Exclusion Criteria: * younger than 18 years old * contraindications for prone position ventilation * past chronic respiratory diseases (long-term family oxygen therapy for chronic * respiratory diseases such as pulmonary fibrosis or COPD) * New York Heart Association class above II * contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician) * severe hemodynamic instability * gave written or witnessed verbal informed consent
Where this trial is running
Nanjing, Jiangsu
- Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: liu ling, phD
- Email: liulingdoctor@126.com
- Phone: 025-83262550
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.