Driving Pressure-guided Lung Protective Ventilation
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
Yong Lin, PhD
43 participants
Jan 26, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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.
Exclusion Criteria8
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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. 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, mechanical ventilation is maintained using the low-level parameters.
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, mechanical ventilation is maintained using the low-level parameters.
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 patients with chronic obstructive pulmonary disease); positive end expiratory pressure: 0 \~ 8 cm centimeter water column. On-pump ventilation parameters are: (1) tidal volume: 4 mL/Kg predictive body weight; (2) respiratory rate: 4 circles per minute; (3) positive end-expiratory pressure: 4 cm centimeter water column; (4) inspiratory oxygen fraction: 21%.
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 concurrent hypercapnia; (6) titrating the fraction of inspiratory oxygen until the pulse oximetry reaches or exceeds 90%; and (7) considering the use of extracorporeal membrane oxygenation if any following situations occurred 14: (a) a partial pressure of arterial oxygen \< 50 mm Hg for more than 3 hours; (b) a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio \< 80 mm Hg for more than 6 hours; or (c) a critical respiratory acidosis for more than 6 hours.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06361420