Driving Pressure-guided Lung Protective Ventilation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Driving pressure-guided positive end expiratory pressure
  The positive end expiratory pressure setting rules are as follows: 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. Partial pressure of carbon dioxide monitoring is employed to determine the tidal volume and respiratory rate
• Процедура 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. Partial pressure of carbon dioxide monitoring is employed to determine the tidal volume and respiratory rate. Inspiration/expiration pattern is adjusted based on the preoperative small airway condition. This parameter is subject to modification upon cessation of ventilation, ICU admission, and every morning throughout the ventilation period. During cardiopulmonary bypass,
• Процедура Ventilation strategy
  A Pressure regulated volume control mode is used in the patients before extubation. The ventilation target are: (1) a pulse oximetry ≥ 90% or a partial pressure of arterial oxygen ≥ 60mm Hg; (2) a partial pressure of arterial carbon dioxide: 35 \~ 50 mm Hg and (3) a pondus hydrogenii (pH) value \> 7.20. The ventilation parameters are: (1) tidal volume: 6 \~ 8 mL/Kg predictive body weight; (2) respiratory rate 10 \~ 15 cycles per minute; (3) inspiratory/expiratory ratio: 1:1.5 (1:2.5 - 1:3 in the
• Процедура Management of hypoxemia
  Management of hypoxemia will be initiated immediately through the following steps: (1) carefully checking anaesthesia apparatus malfunction, airway normality, and monitoring accuracy; (2) improving cardiac function, correcting fluid overload, and alleviating systemic inflammation; (3) performing alveolar recruitment manoeuvres as described above; (4) increasing the tidal volume and positive end expiratory pressure within the upper limits; (5) increasing the respiratory rate while addressing conc

Первичные конечные точки

• The incidence of postoperative hypoxemia [Срок оценки: Within 7 days after surgery]

Вторичные конечные точки (8)

• The trend of perioperative oxygenation function [Срок оценки: Within 7 days after surgery]
• Postoperative pulmonary complications except hypoxemia [Срок оценки: Within 7 days after surgery]
• Early/late death [Срок оценки: Within 30 days after surgery]
• Vasoactive-inotropic score at the end of surgery [Срок оценки: Within 7 days after surgery]
• Postoperative adverse cardiovascular events [Срок оценки: Within 7 days after surgery]
• Length of stay in intensive care unit [Срок оценки: Within 30 days after surgery]
• Ventilation assistance time [Срок оценки: Depending on the time point of extubation, not exceeding 30 days]
• Postoperative extrapulmonary complications [Срок оценки: Within 7 days after surgery]

Критерии участия

Критерии включения

• Able to sign Informed Consent and Release of Medical Information Forms;
• Age ≥ 14 years and ≤ 70 years old;
• Being confirmed the diagnosis by chest computed tomography angiography and receiving the surgical repair of acute type A aortic dissection.

Критерии исключения

• Age < 14 years or > 70 years old;
• Sepsis before surgery;
• Chronic pulmonary disease including lung infection or asthma requiring long-term pharmacotherapy;
• History of lung tumor;
• Obstructive sleep apnea hypopnea syndrome requiring long-term noninvasive mechanical ventilation support;
• Heart failure requiring catecholamines or invasive mechanical ventilation support;
• Body mass index > 30 Kg·m-2;
• Being reluctance to participate this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Fujian medical university union hospital — Фучжоу

Идентификаторы

NCT: NCT06361420 · 2023YF051-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗