Using driving pressure to improve lung ventilation after aortic dissection surgery
The Efficacy of Driving Pressure-guided Lung Protective Ventilation in Surgical Repair of Acute Type A Aortic Dissection: an Open-label, Randomized Control Clinical Trial
This study is testing if a special way of helping patients breathe after aortic dissection surgery can lower the chances of low oxygen levels in their blood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 14 Years to 70 Years |
| Sex | All |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06361420 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of driving pressure-guided lung protective ventilation in reducing postoperative hypoxemia in patients who have undergone surgical repair of acute type A aortic dissection. The study is an open-label, randomized control trial that aims to measure the incidence of hypoxemia within seven days post-surgery, defined by specific arterial oxygen levels. By utilizing driving pressure as a ventilation strategy, the trial seeks to improve oxygenation outcomes and reduce complications associated with this high-risk surgical procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 14 to 70 years who are undergoing surgical repair for acute type A aortic dissection.
Not a fit: Patients with chronic pulmonary diseases, significant obesity, or those requiring long-term mechanical ventilation support may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative hypoxemia and improve recovery outcomes for patients undergoing surgery for acute type A aortic dissection.
How similar studies have performed: Previous studies have shown that driving pressure is associated with improved survival in acute respiratory distress syndrome, suggesting potential success for this novel approach in a surgical context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Able to sign Informed Consent and Release of Medical Information Forms; 2. Age ≥ 14 years and ≤ 70 years old; 3. Being confirmed the diagnosis by chest computed tomography angiography and receiving the surgical repair of acute type A aortic dissection. Exclusion Criteria: 1. Age \< 14 years or \> 70 years old; 2. Sepsis before surgery; 3. Chronic pulmonary disease including lung infection or asthma requiring long-term pharmacotherapy; 4. History of lung tumor; 5. Obstructive sleep apnea hypopnea syndrome requiring long-term noninvasive mechanical ventilation support; 6. Heart failure requiring catecholamines or invasive mechanical ventilation support; 7. Body mass index \> 30 Kg·m-2; 8. Being reluctance to participate this study.
Where this trial is running
Fuzhou, Fujian
- Fujian medical university union hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Yong Lin, MD — Fujian Medical University Union Hospital
- Study coordinator: Yong Lin, MD
- Email: birdman1983@163.com
- Phone: 13805064575
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.