Actively Recruiting
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
Led by Yong Lin, PhD · Updated on 2025-08-11
43
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether a lung ventilation method guided by driving pressure can reduce the occurrence of low oxygen levels after surgery in patients who have had emergency repair for acute type A aortic dissection. This serious condition requires urgent surgery, and many patients experience low oxygen levels after this procedure, which can lead to complications like longer time on ventilators, longer ICU stays, and higher risk of death. The study seeks to provide clearer evidence on the benefits of this ventilation approach. Participants will receive either driving pressure-guided lung protective ventilation or conventional lung protective ventilation during their surgery. The driving pressure method involves testing different positive end expiratory pressure (PEEP) levels in cycles after intubation to find the optimal setting that results in the lowest driving pressure. This optimal PEEP is maintained during the off-pump period. Ventilation parameters such as tidal volume, respiratory rate, and inhalation/exhalation patterns are adjusted based on monitoring and patient lung condition. Management of low oxygen levels involves several steps including checking equipment, improving heart function, adjusting ventilation settings, and considering advanced support if needed. During the study, researchers will monitor oxygen levels and lung function closely for up to 7 days after surgery, along with tracking other complications, heart events, time on ventilation, and ICU stay length. Various measurements including blood oxygen levels and ventilation settings will be recorded daily, and participants will be followed for up to 30 days to assess early and late outcomes. Safety and treatment effects will be assessed throughout this period, with the primary focus on the rate of low oxygen episodes within the first week after surgery.
CONDITIONS
Brief Title
Driving Pressure-guided Lung Protective Ventilation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to sign informed consent and release of medical information forms
- Age 14 years or older and 70 years or younger
- Confirmed diagnosis by chest computed tomography angiography and scheduled for surgical repair of acute type A aortic dissection
You will not qualify if you...
- Age younger than 14 years or older than 70 years
- Presence of sepsis before surgery
- Chronic pulmonary diseases including lung infection or asthma requiring long-term medication
- History of lung tumor
- Obstructive sleep apnea hypopnea syndrome needing long-term noninvasive mechanical ventilation
- Heart failure requiring catecholamines or invasive mechanical ventilation
- Body mass index greater than 30 kg/m²
- Unwillingness to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the end of surgery and immediate post-operative period
Participants undergo emergency surgery for acute type A aortic dissection with lung protective ventilation guided by driving pressure or optimal oxygenation settings. Mechanical ventilation parameters are adjusted during surgery and immediately after to protect lung function.
1 visit during surgery and ICU admission
Duration - Up to 7 days after surgery
Participants receive lung protective ventilation and management of hypoxemia as needed in the ICU. Ventilation parameters and oxygenation are monitored and adjusted daily to prevent hypoxemia and pulmonary complications.
Daily visits in ICU for up to 7 days
Duration - Up to 30 days after surgery
Participants are monitored for survival, cardiovascular events, and length of ICU stay up to 30 days after surgery.
Periodic assessments up to 30 days
Trial Site Locations
Total: 1 location
1
Fujian medical university union hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
Y
Yong Lin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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