Clinical trial NCT06361420: Driving Pressure-guided Lung Protective Ventilation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxemia
Ventilator Lung
Keywords: Driving Pressure
Lung Protective Ventilation
Aortic Dissection
Hypoxia
Postoperative Pulmonary Complications
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 43
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open, randomised control trial
Primary purpose: PREVENTION

Brief summary: The study, named as "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", aims to investigate whether driving pressure-guided lung protective ventilation can reduce postoperative oxygenation function in patients who have undergone surgical repair of acute type A aortic dissection. The primary outcomes is the incidence of postoperative hypoxemia (a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a peripheral blood oxygen saturation less than 93% at any concentration of inspiratory oxygen) within 7 days after the surgery.

Detailed description: Postoperative hypoxemia is defined as a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a peripheral blood oxygen saturation less than 93% at any concentration of inspiratory oxygen. Acute type A aortic dissection is a lethal disease requiring emergency surgery. Compared with non-cardiac surgery, hypoxemia frequently occurs after surgical repair for acute type A aortic dissection which has been reported to be 52%-67.6%, and the possible mechanisms are as followed: (1) systemic inflammatory reaction induced by massive thrombosis formation and long duration of extracorporeal circulation; (2) ischemia-perfusion injury in lung; and (3) a massive perioperative transfusion. Postoperative hypoxemia has been reported to be associated with prolonged duration of extubation, length of stay in ICU and respiratory failure, which contributes a high mortality of 20% to 44%.

Driving pressure, defined as the difference between platform airway pressure and positive end-expiratory pressure, was first introduced by Amato and his colleagues in their meta-analysis study on acute respiratory distress syndrome in 2015, demonstrating that driving pressure was most strongly associated with survival among various ventilation parameters. A lower driving pressure has been verified to be closely relative to an ameliorative prognosis after surgery. However, controversy persists regarding whether driving pressure-guided ventilation can decrease the incidences of postoperative hypoxemia and other pulmonary complications in the patients underwent surgical repair of acute type A aortic dissection.

Given the need for additional evidence to confirm the relationship between driving pressure and postoperative hypoxemia in the patients with acute type A aortic dissection, this open-label, randomized control clinical trial aims to assess the efficacy and safety of the driving pressure-guided lung protective ventilation strategy in preventing hypoxemia and other pulmonary complications after the surgical repair for acute type A aortic dissection.

Eligibility 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.

Primary outcomes:
measure: The incidence of postoperative hypoxemia
timeFrame: Within 7 days after surgery
Secondary outcomes:
measure: The trend of perioperative oxygenation function
timeFrame: Within 7 days after surgery
measure: Postoperative pulmonary complications except hypoxemia
timeFrame: Within 7 days after surgery
measure: Early/late death
timeFrame: Within 30 days after surgery
measure: Vasoactive-inotropic score at the end of surgery
timeFrame: Within 7 days after surgery
measure: Postoperative adverse cardiovascular events
timeFrame: Within 7 days after surgery
measure: Length of stay in intensive care unit
timeFrame: Within 30 days after surgery
measure: Ventilation assistance time
timeFrame: Depending on the time point of extubation, not exceeding 30 days
measure: Postoperative extrapulmonary complications
timeFrame: Within 7 days after surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian medical university union hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Yong Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: