Individualized PEEP Titration on Postoperative Pulmonary Complications

July 8, 2025 updated by: Shanghai Zhongshan Hospital

Effect of Individualized PEEP Titration on Postoperative Pulmonary Complications in Elderly Patients Undergoing Major Laparoscopic Surgery- A Multicenter Randomized Controlled Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 200032
        • 180 Fenglin Road
      • Shanghai, China
        • Shanghai Geriatric Medical Center
      • Xiamen, China
        • Zhongshan Hospital (Xiamen), Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
After endotracheal intubation, an esophageal balloon is placed and calibrated for accurate positioning and inflation pressure. Continuous monitoring of end-expiratory esophageal pressure (Pes) is conducted. Fixed PEEP of 3 cmH2O is applied throughout the procedure without lung recruitment maneuvers.
Experimental: Pes-Guided Group
After endotracheal intubation, an esophageal balloon is placed and calibrated for accurate positioning and inflation pressure. Continuous monitoring of end-expiratory esophageal pressure (Pes) is conducted. Lung recruitment is performed at each time point. After lung recruitment, ventilation is adjusted based on the target PEEP. PEEP is chosen to maintain a positive transpulmonary pressure at end-expiration (PL = PEEP - Pes). PEEP titration following lung recruitment should be performed within 1 hour 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.
Procedure: Pes-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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
postoperative pulmonary complications
Time Frame: within 7 days after surgery
the incidence of postoperative pulmonary complications
within 7 days after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
airway peak pressure (cmH2O)
Time Frame: intraoperative
intraoperative mechanical ventilation parameters
intraoperative
driving pressure (cmH2O)
Time Frame: intraoperative
intraoperative mechanical ventilation parameters
intraoperative
dynamic lung compliance (mL/cmH20)
Time Frame: intraoperative
Cdyn = Vt/(Ppeak - PEEP)
intraoperative
unplanned reintubation
Time Frame: day 1 to day 7 after surgery
the incidence of unplanned reintubation
day 1 to day 7 after surgery
unplanned transfer to the ICU
Time Frame: day 1 to day 7 after surgery
the incidence of unplanned transfer to the ICU
day 1 to day 7 after surgery
duration of ICU stay
Time Frame: day 1 after surgery to the day of discharge, assessed up to 90 days
duration of ICU stay
day 1 after surgery to the day of discharge, assessed up to 90 days
length of hospital stay
Time Frame: 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
from the day of admission to the day of discharge, assessed up to 90 days
plateau pressure
Time Frame: intraoperative
intraoperative mechanical ventilation parameters
intraoperative
positive end-expiratory pressure
Time Frame: intraoperative
intraoperative mechanical ventilation parameters
intraoperative
Interleukin-6 level
Time Frame: before surgery, before the end of surgery and in post-anesthetic care unit
biological indices, result from blood sample
before surgery, before the end of surgery and in post-anesthetic care unit
Clara cell secretory protein-16 level
Time Frame: before surgery, before the end of surgery and in post-anesthetic care unit
biological indices, result from blood samples
before surgery, before the end of surgery and in post-anesthetic care unit
soluble receptor for advanced glycation end product level
Time Frame: before surgery, before the end of surgery and in post-anesthetic care unit
biological indices, result from blood samples
before surgery, before the end of surgery and in post-anesthetic care unit
angiopoietin-2 level
Time Frame: before surgery, before the end of surgery and in post-anesthetic care unit
biological indices, result from blood samples
before surgery, before the end of surgery and in post-anesthetic care unit
plasminogen activator inhibitor-1
Time Frame: before surgery, before the end of surgery and in post-anesthetic care unit
biological indices, result from blood samples
before surgery, before the end of surgery and in post-anesthetic care unit
static compliance (mL/cmH20)
Time Frame: intraoperative
pulmonary compliance measured at a fixed volume with no airflow and fully relaxed muscles. static compliance = VT / (Pplat - PEEP)
intraoperative
PaO2/FiO2 ratio
Time Frame: 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
before surgery, intraoperative, and in post-anesthetic care unit
non-respiratory complications
Time Frame: within 7 days after surgery
the incidence of stroke, myocardial infarction, acute renal failure, DIC, SIRS, sepsis, septic shock, wound infection
within 7 days after surgery
QoR-15 scores
Time Frame: day 1 and day 7 after surgery, the day of discharge
early quality of recovery
day 1 and day 7 after surgery, the day of discharge
mortality rates
Time Frame: at 90 days after surgery
mortality rates
at 90 days after surgery
complications
Time Frame: at 30 days after surgery
including postoperative respiratory and non-respiratory complications
at 30 days after surgery
vital signs
Time Frame: 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
admission to operating room to day 7 after surgery, and the day of discharge
esophageal pressure (Pes)
Time Frame: intraoperative
a classical and most widely used marker of pleural pressure which is usually measured by air-filled balloons
intraoperative
transpulmonary pressure (PL)
Time Frame: intraoperative
equal to the difference between alveolar pressure and pleural pressure
intraoperative
Vasoactive medications dosages
Time Frame: intraoperative
Vasoactive medications includes norepinephrine, phenylephrine, ephedrine
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhongshan Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fudan University
Zhongshan Hospital (Xiamen), Fudan University
Shanghai Geriatric Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Changhong Miao, Zhongshang Hospital Fudan University
  • Principal Investigator: Jing Zhong, Zhongshang Hospital Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2023-334R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data generated during the study will be made available on reasonable request to qualified researchers, following publication of the primary results, and in accordance with institutional and ethical guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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