Driving Pressure-guided Lung Protective Ventilation (DPV)

Yong Lin, PhD

Status: Enrolling

Conditions: Ventilator Lung; Hypoxemia

Treatments: Procedure: Optimal oxygenation-guided positive end expiratory pressure; Procedure: Ventilation strategy; Procedure: Management of hypoxemia; Procedure: Driving pressure-guided positive end expiratory pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT06361420

2023YF051-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 estimated patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Driving pressure-guided lung protective ventilation during the surgery

Experimental group

Description:

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.

Treatment:

Procedure: Management of hypoxemia

Procedure: Driving pressure-guided positive end expiratory pressure

Procedure: Ventilation strategy

Conventional lung protective ventilation

Other group

Description:

Positive end expiratory pressure will be maintained at the level facilitating optimal oxygenation during the off-pump period.

Treatment:

Procedure: Management of hypoxemia

Procedure: Ventilation strategy

Procedure: Optimal oxygenation-guided positive end expiratory pressure