Driving Pressure-guided Lung Protective Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-70
SponsorYong Lin, PhD
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Driving pressure-guided positive end expiratory pressure
Procedure/SurgeryThe 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.
Optimal oxygenation-guided positive end expiratory pressure
Procedure/SurgeryPositive 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.
Ventilation strategy
Procedure/SurgeryA 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
Procedure/SurgeryManagement 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.
Treatment groups
43 Participants
are divided into 2 treatment groupsGroup A: Driving pressure-guided lung protective ventilation during the surgeryExperimental treatment 3 interventions
Group B: Conventional lung protective ventilationOther 3 interventions
Trial outcomes
Primary outcomes
1
The incidence of postoperative hypoxemia
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.
Time frame
Within 7 days after surgerySecondary outcomes
1
The trend of perioperative oxygenation function
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).
Time frame
Within 7 days after surgery2
Postoperative pulmonary complications except hypoxemia
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.
Time frame
Within 7 days after surgery3
Early/late death
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.
Time frame
Within 30 days after surgery4
Vasoactive-inotropic score at the end of 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).
Time frame
Within 7 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Yong Lin, PhD
Lead sponsor
Fujian Medical University Union Hospital
Sponsor institution
Source ClinicalTrials.gov