Individualized PEEP Titration on Postoperative Pulmonary Complications

Shanghai Zhongshan Hospital240 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

240

Conditions

Postoperative Pulmonary Complications Positive End-expiratory Pressure Elderly Laparoscopic Surgery

Interventions

Pes-Guided PEEP titrationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (4)

180 Fenglin Road

Shanghai, China

Fudan University Shanghai Cancer Center

Shanghai, China

Shanghai Geriatric Medical Center

Shanghai, China

Zhongshan Hospital (Xiamen), Fudan University

Xiamen, China

Outcomes

Primary Outcomes

postoperative pulmonary complications

the incidence of postoperative pulmonary complications

Time frame: within 7 days after surgery

Secondary Outcomes

airway peak pressure (cmH2O)

intraoperative mechanical ventilation parameters

Time frame: intraoperative

plateau pressure

intraoperative mechanical ventilation parameters

Time frame: intraoperative

positive end-expiratory pressure

intraoperative mechanical ventilation parameters

Time frame: intraoperative

esophageal pressure (Pes)

a classical and most widely used marker of pleural pressure which is usually measured by air-filled balloons

Time frame: intraoperative

driving pressure (cmH2O)

intraoperative mechanical ventilation parameters

Time frame: intraoperative

transpulmonary pressure (PL)

equal to the difference between alveolar pressure and pleural pressure

Time frame: intraoperative

dynamic lung compliance (mL/cmH20)

Cdyn = Vt/(Ppeak - PEEP)

Time frame: intraoperative

static compliance (mL/cmH20)

Data from ClinicalTrials.gov

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