Status:
COMPLETED
Individualized PEEP Titration on Postoperative Pulmonary Complications
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Shanghai Geriatric Medical Center
Zhongshan Hospital (Xiamen), Fudan University
Conditions:
Postoperative Pulmonary Complications
Positive End-expiratory Pressure
Eligibility:
All Genders
65+ years
Phase:
NA
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 i...
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 exclusi...
Eligibility Criteria
Inclusion
- Patients aged 65 years or older, male or female
- Scheduled to perform major laparoscopic surgery under general anesthesia
- Expected duration of surgery ≥ 2 hours
- Written informed consent is obtainable either from the patient or from a legal surrogate
Exclusion
- BMI ≥ 35 kg/m2.
- History of pulmonary surgery (of any type).
- History of severe chronic obstructive pulmonary disease (COPD) requiring non-invasive ventilation and/or home oxygen therapy.
- Patients on systemic corticosteroid treatment for acute chronic obstructive pulmonary disease exacerbation.
- Severe pulmonary arterial hypertension, defined as systolic pulmonary artery pressure \> 40 mmHg.
- 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).
- 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).
- Severe liver or renal dysfunction (Child-Pugh score 10-15, serum creatinine ≥ 2 mg/dL, or patients requiring peritoneal dialysis or hemodialysis).
- Neuromuscular disease (of any type).
- History of bone marrow transplantation or recent history of immunosuppressive drugs (chemotherapy or radiotherapy within 2 months before surgery).
- Mechanical ventilation duration \> 30 minutes within the past 30 days (e.g., surgery under general anesthesia).
- Requirement for one-lung ventilation.
- History of acute respiratory distress syndrome with potential need for prolonged postoperative mechanical ventilation.
- Planned re-intubation after surgery.
- Pregnancy (excluded by medical history and/or laboratory tests).
- Brain injury or tumor.
- Requirement for prone or lateral position during surgery.
- Severe esophagogastric varices.
- Enrollment in other interventional studies or refusal to sign informed consent.
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06150079
Start Date
November 30 2023
End Date
February 9 2025
Last Update
July 11 2025
Active Locations (4)
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1
180 Fenglin Road
Shanghai, China, 200032
2
Fudan University Shanghai Cancer Center
Shanghai, China
3
Shanghai Geriatric Medical Center
Shanghai, China
4
Zhongshan Hospital (Xiamen), Fudan University
Xiamen, China