Elderly, Laparoscopic Surgery, Positive End-expiratory Pressure, Postoperative Pulmonary Complications
Conditions
Brief summary
This study aims to investigate the effectiveness and safety of implementing a personalized positive end-expiratory pressure (PEEP) management strategy guided by esophageal pressure (Pes), as well as its potential to reduce the occurrence of postoperative pulmonary complications (PPCs) in elderly patients undergoing laparoscopic surgery.
Detailed description
This trial is a single-blind, randomized, controlled, multicenter study. Elderly patients undergoing laparoscopic surgery under general anesthesia will be recruited according the inclusion and exclusion criteria. Participants in this study will be randomly assigned into two groups. The total sample size will be 232, with 116 participants in the experimental group and 116 participants in the control group. A stratified block randomization method will be employed, using the ARISCAT score for PPCs risk assessment and individual study centers as stratification factors. Anesthesia routine will be applied during pre-anesthetic preparation, anesthetic induction, maintenance and emergence except intraoperative respiratory management. In the control group, fixed PEEP of 3 cmH2O is applied throughout the procedure without lung recruitment maneuvers. While in the experimental group (Pes-Guided Group), continuous monitoring of end-expiratory esophageal pressure (Pes) is conducted. PEEP is chosen to maintain a positive transpulmonary pressure at end-expiration (PL = PEEP - Pes) after lung recruitment. PEEP titration following lung recruitment should be performed after endotracheal intubation or any procedure that may cause lung collapse, such as pneumoperitoneum, deflation or inflation of the endotracheal tube cuff, changes in position, or endotracheal suctioning. PEEP Titration is also required every hour after the establishment of pneumoperitoneum. Patients will be followed up within 7 days after surgery to assess basic vital signs, potential postoperative pulmonary complications (PPCs). Additionally, postoperative non-respiratory complications will be evaluated. Laboratory tests, the 15-item Quality of Recovery-15 (QoR-15) questionnaire, complications within 30 days after surgery, and 90-day survival rates will also be recorded.
Interventions
PROCEDUREPes-Guided PEEP titration
Lung recruitment is performed at each time point, involving a switch from volume-controlled (VCV) mode to pressure-controlled (PCV) mode with a pressure setting of 20 cmH2O, RR of 15 bpm, I:E ratio of 1:1, FiO2 of 0.4, and PEEP of 5 cmH2O. During lung recruitment, PEEP is gradually increased in increments of 5 cmH2O, maintained for 5 respiratory cycles until PEEP reaches 20 cmH2O and airway pressure reaches 40 cmH2O, and then maintained for 10 respiratory cycles. After lung recruitment, ventilation is adjusted based on the target PEEP. Each PEEP titration should ensure adequate muscle relaxation, volume status, and hemodynamic stability. PEEP is chosen to maintain a positive transpulmonary pressure at end-expiration (PL = PEEP - Pes). Each PEEP titration should ensure adequate muscle relaxation, volume status, and hemodynamic stability.
Sponsors
Shanghai Geriatric Medical Center
Zhongshan Hospital (Xiamen), Fudan University
Fudan University
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 65 years or older, male or female 2. Scheduled to perform major laparoscopic surgery under general anesthesia 3. Expected duration of surgery ≥ 2 hours 4. Written informed consent is obtainable either from the patient or from a legal surrogate
Exclusion criteria
1. BMI ≥ 35 kg/m2. 2. History of pulmonary surgery (of any type). 3. History of severe chronic obstructive pulmonary disease (COPD) requiring non-invasive ventilation and/or home oxygen therapy. 4. Patients on systemic corticosteroid treatment for acute chronic obstructive pulmonary disease exacerbation. 5. Severe pulmonary arterial hypertension, defined as systolic pulmonary artery pressure \> 40 mmHg. 6. Heart failure according to the New York Heart Association classification (class III or IV), ongoing hemodynamic instability, or severe shock (determined by the attending internist, cardiac index \< 2.5 L/min/m2, or the requirement for positive inotropic drugs to maintain blood pressure). 7. Severe cardiac disease (acute coronary syndrome according to Canadian Cardiovascular Society, atrial flutter/fibrillation, sustained ventricular tachyarrhythmias, metabolic equivalent of tasks (METs) \< 4) (METs \< 4, determined by the inability to climb ≥ 2 flights of stairs). 8. Severe liver or renal dysfunction (Child-Pugh score 10-15, serum creatinine ≥ 2 mg/dL, or patients requiring peritoneal dialysis or hemodialysis). 9. Neuromuscular disease (of any type). 10. History of bone marrow transplantation or recent history of immunosuppressive drugs (chemotherapy or radiotherapy within 2 months before surgery). 11. Mechanical ventilation duration \> 30 minutes within the past 30 days (e.g., surgery under general anesthesia). 12. Requirement for one-lung ventilation. 13. History of acute respiratory distress syndrome with potential need for prolonged postoperative mechanical ventilation. 14. Planned re-intubation after surgery. 15. Pregnancy (excluded by medical history and/or laboratory tests). 16. Brain injury or tumor. 17. Requirement for prone or lateral position during surgery. 18. Severe esophagogastric varices. 19. Enrollment in other interventional studies or refusal to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pulmonary complications | within 7 days after surgery | the incidence of postoperative pulmonary complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| esophageal pressure (Pes) | intraoperative | a classical and most widely used marker of pleural pressure which is usually measured by air-filled balloons |
| driving pressure (cmH2O) | intraoperative | intraoperative mechanical ventilation parameters |
| airway peak pressure (cmH2O) | intraoperative | intraoperative mechanical ventilation parameters |
| plateau pressure | intraoperative | intraoperative mechanical ventilation parameters |
| transpulmonary pressure (PL) | intraoperative | equal to the difference between alveolar pressure and pleural pressure |
| dynamic lung compliance (mL/cmH20) | intraoperative | Cdyn = Vt/(Ppeak - PEEP) |
| static compliance (mL/cmH20) | intraoperative | pulmonary compliance measured at a fixed volume with no airflow and fully relaxed muscles. static compliance = VT / (Pplat - PEEP) |
| PaO2/FiO2 ratio | before surgery, intraoperative, and in post-anesthetic care unit | the ratio of partial pressure of oxygen in arterial blood (PaO2) to the fraction of inspiratory oxygen concentration (FiO2), measured through blood gas analysis |
| non-respiratory complications | within 7 days after surgery | the incidence of stroke, myocardial infarction, acute renal failure, DIC, SIRS, sepsis, septic shock, wound infection |
| QoR-15 scores | day 1 and day 7 after surgery, the day of discharge | early quality of recovery |
| unplanned reintubation | day 1 to day 7 after surgery | the incidence of unplanned reintubation |
| positive end-expiratory pressure | intraoperative | intraoperative mechanical ventilation parameters |
| duration of ICU stay | day 1 after surgery to the day of discharge, assessed up to 90 days | duration of ICU stay |
| length of hospital stay | from the day of admission to the day of discharge, assessed up to 90 days | the number of days from a patient's hospital admission to discharge |
| Interleukin-6 level | before surgery, before the end of surgery and in post-anesthetic care unit | biological indices, result from blood sample |
| Clara cell secretory protein-16 level | before surgery, before the end of surgery and in post-anesthetic care unit | biological indices, result from blood samples |
| soluble receptor for advanced glycation end product level | before surgery, before the end of surgery and in post-anesthetic care unit | biological indices, result from blood samples |
| angiopoietin-2 level | before surgery, before the end of surgery and in post-anesthetic care unit | biological indices, result from blood samples |
| plasminogen activator inhibitor-1 | before surgery, before the end of surgery and in post-anesthetic care unit | biological indices, result from blood samples |
| mortality rates | at 90 days after surgery | mortality rates |
| complications | at 30 days after surgery | including postoperative respiratory and non-respiratory complications |
| vital signs | admission to operating room to day 7 after surgery, and the day of discharge | vital signs will be recorded at any key time points from admission to operating room to extubation |
| Vasoactive medications dosages | intraoperative | Vasoactive medications includes norepinephrine, phenylephrine, ephedrine |
| unplanned transfer to the ICU | day 1 to day 7 after surgery | the incidence of unplanned transfer to the ICU |
Countries
China
Outcome results
None listed