Individualized PEEP Titration on Postoperative Pulmonary Complications

Not Applicable

Completed

• Conditions: Laparoscopic Surgery; Postoperative Pulmonary Complications; Positive End-expiratory Pressure; Elderly

• Registration Number: NCT06150079
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2023-11-11
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-11-29
• Study Start: 2023-11-30
• Primary Completion: 2024-11-18
• Study Completion: 2025-02-09
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
postoperative pulmonary complications	within 7 days after surgery	the incidence of postoperative pulmonary complications

Secondary Outcome Measures

Name	Time	Method
airway peak pressure (cmH2O)	intraoperative	intraoperative mechanical ventilation parameters
plateau pressure	intraoperative	intraoperative mechanical ventilation parameters
positive end-expiratory pressure	intraoperative	intraoperative mechanical ventilation parameters
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
dynamic lung compliance (mL/cmH20)	intraoperative	Cdyn = Vt/(Ppeak - PEEP)
transpulmonary pressure (PL)	intraoperative	equal to the difference between alveolar pressure and pleural pressure
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
Interleukin-6 level	before surgery, before the end of surgery and in post-anesthetic care unit	biological indices, result from blood sample
unplanned transfer to the ICU	day 1 to day 7 after surgery	the incidence of unplanned transfer to the ICU
angiopoietin-2 level	before surgery, before the end of surgery and in post-anesthetic care unit	biological indices, result from blood samples
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
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
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

Trial Locations

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