Driving Pressure-guided Lung Protective Ventilation

Not Applicable

Recruiting

• Conditions: Hypoxemia; Ventilator Lung
• Interventions: Procedure: Driving pressure-guided positive end expiratory pressure; Procedure: Optimal oxygenation-guided positive end expiratory pressure; Procedure: Ventilation strategy; Procedure: Management of hypoxemia

• Registration Number: NCT06361420
• Lead Sponsor: Yong Lin, PhD

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.

Study Timeline

• Study Start: 2024-01-26
• Study First Submitted: 2024-03-10
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Primary Completion: 2024-12-30
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Driving pressure-guided lung protective ventilation during the surgery	Ventilation strategy	A 10-cycle experimental ventilation will be carried out at each level of positive end expiratory pressure after intubation, and the driving pressure of the last cycle will be recorded. The positive end expiratory pressure value corresponding to the lowest driving pressure is recognised as the optimal ventilation parameter.
Conventional lung protective ventilation	Management of hypoxemia	Positive end expiratory pressure will be maintained at the level facilitating optimal oxygenation during the off-pump period.
Driving pressure-guided lung protective ventilation during the surgery	Driving pressure-guided positive end expiratory pressure	A 10-cycle experimental ventilation will be carried out at each level of positive end expiratory pressure after intubation, and the driving pressure of the last cycle will be recorded. The positive end expiratory pressure value corresponding to the lowest driving pressure is recognised as the optimal ventilation parameter.
Driving pressure-guided lung protective ventilation during the surgery	Management of hypoxemia	A 10-cycle experimental ventilation will be carried out at each level of positive end expiratory pressure after intubation, and the driving pressure of the last cycle will be recorded. The positive end expiratory pressure value corresponding to the lowest driving pressure is recognised as the optimal ventilation parameter.
Conventional lung protective ventilation	Optimal oxygenation-guided positive end expiratory pressure	Positive end expiratory pressure will be maintained at the level facilitating optimal oxygenation during the off-pump period.
Conventional lung protective ventilation	Ventilation strategy	Positive end expiratory pressure will be maintained at the level facilitating optimal oxygenation during the off-pump period.

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative hypoxemia	Within 7 days after surgery	Postoperative hypoxemia is defined as a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a pulse oximetry less than 93% at any concentration of inspiratory oxygen that occurred from admission to the operating room to 7 days post-surgery.

Secondary Outcome Measures

Name	Time	Method
The trend of perioperative oxygenation function	Within 7 days after surgery	An automated blood gas analyzer will be applied for arterial blood gas analyses, with the time points: T1 (before surgery), T2 (after intubation), T3 (withdrawal from cardiopulmonary bypass), T4 (end of surgery), T5 (postoperative day 1), T6 (postoperative day 3), T7 (postoperative day 5), and T8 (postoperative day 7).
Length of stay in intensive care unit	Within 30 days after surgery	The duration from admission to discharge of the ICU
Early/late death	Within 30 days after surgery	Early death was defined as any death occurring within 72 hours of surgery, while late death was considered for deaths occurring within 30 days after the surgery was scheduled.
Vasoactive-inotropic score at the end of surgery	Within 7 days after surgery	The vasoactive-inotropic score is the sum of the dosages of frequently used vasoactive or inotropic agents according to the weighted values of the enrolled patients. Vasoactive-Inotropic Score = dopamine dose (μg·kg-1·min-1) + dobutamine dose (μg·kg-1·min-1) + 100 × epinephrine dose (μg·kg-1·min-1) + 10 × phosphodiesterase inhibitor (milrinone or olprinone) dose (μg·kg-1·min-1) + 100 × norepinephrine dose (μg·kg-1·min-1) +10000 × vasopressin dose (U·kg-1·min-1).
Ventilation assistance time	Depending on the time point of extubation, not exceeding 30 days	Duration from the end of the surgery to extubation.
Postoperative extrapulmonary complications	Within 7 days after surgery	Postoperative extrapulmonary complications include tracheotomy, rethoracotomy for exploration, wound infection, sepsis, gastrointestinal haemorrhage, and neurological complications (such as delayed recovery, delirium, cognitive dysfunction, coma, new-onset stroke, and syncope)
Postoperative pulmonary complications except hypoxemia	Within 7 days after surgery	Postoperative pulmonary complications are defined as any postoperative respiratory system complication that occurs from admission to the intensive care unit to 7 days post-surgery, encompassing (1) respiratory infection, (2) respiratory failure, (3) bronchospasm, (4) atelectasis, (5) pleural effusion, (6) pneumothorax, and (7) aspiration pneumonitis.
Postoperative adverse cardiovascular events	Within 7 days after surgery	The postoperative adverse cardiovascular events include new-onset lethal arrhythmias (supraventricular/ventricular tachycardia, ventricular fibrillation, or Adams-Stokes syndrome), acute myocardial infarction, cardiogenic shock, and thrombotic or embolic events.

Trial Locations

Locations (1)

Fujian medical university union hospital; 🇨🇳 Fuzhou, Fujian, China