AzTrials
AzTrials

Postoperative Pulmonary ComplicationsNCT06150079

Individualized PEEP Titration on Postoperative Pulmonary Complications

A study testing Pes-Guided PEEP titration in people with Postoperative Pulmonary Complications and Positive End-expiratory Pressure, run by Shanghai Zhongshan Hospital at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Pes-Guided PEEP titration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
4 sitesChina
Study dates
30 Nov 2023to 9 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 19Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • 180 Fenglin Road

    Shanghai, 200032

  • Fudan University Shanghai Cancer Center

    Shanghai

  • Shanghai Geriatric Medical Center

    Shanghai

  • Zhongshan Hospital (Xiamen), Fudan University

    Xiamen

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Pes-Guided PEEP titration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pes-Guided PEEP titrationProcedure or surgery

    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.

Study groups in NCT06150079
Study groupRoleWhat they receive
Control GroupNo interventionAfter 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.
Pes-Guided GroupExperimentalAfter 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.
Receives: Procedure: Pes-Guided PEEP titration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative pulmonary complications

    the incidence of postoperative pulmonary complications

    Measured: within 7 days after surgery

Secondary outcomes (24)

  1. airway peak pressure (cmH2O)

    intraoperative mechanical ventilation parameters

    Measured: intraoperative

  2. plateau pressure

    intraoperative mechanical ventilation parameters

    Measured: intraoperative

  3. positive end-expiratory pressure

    intraoperative mechanical ventilation parameters

    Measured: intraoperative

  4. esophageal pressure (Pes)

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

    Measured: intraoperative

  5. driving pressure (cmH2O)

    intraoperative mechanical ventilation parameters

    Measured: intraoperative

  6. transpulmonary pressure (PL)

    equal to the difference between alveolar pressure and pleural pressure

    Measured: intraoperative

  7. dynamic lung compliance (mL/cmH20)

    Cdyn = Vt/(Ppeak - PEEP)

    Measured: intraoperative

  8. static compliance (mL/cmH20)

    pulmonary compliance measured at a fixed volume with no airflow and fully relaxed muscles. static compliance = VT / (Pplat - PEEP)

    Measured: intraoperative

  9. PaO2/FiO2 ratio

    the ratio of partial pressure of oxygen in arterial blood (PaO2) to the fraction of inspiratory oxygen concentration (FiO2), measured through blood gas analysis

    Measured: before surgery, intraoperative, and in post-anesthetic care unit

  10. non-respiratory complications

    the incidence of stroke, myocardial infarction, acute renal failure, DIC, SIRS, sepsis, septic shock, wound infection

    Measured: within 7 days after surgery

  11. QoR-15 scores

    early quality of recovery

    Measured: day 1 and day 7 after surgery, the day of discharge

  12. unplanned reintubation

    the incidence of unplanned reintubation

    Measured: day 1 to day 7 after surgery

  13. unplanned transfer to the ICU

    the incidence of unplanned transfer to the ICU

    Measured: day 1 to day 7 after surgery

  14. duration of ICU stay

    duration of ICU stay

    Measured: day 1 after surgery to the day of discharge, assessed up to 90 days

  15. length of hospital stay

    the number of days from a patient's hospital admission to discharge

    Measured: from the day of admission to the day of discharge, assessed up to 90 days

  16. Interleukin-6 level

    biological indices, result from blood sample

    Measured: before surgery, before the end of surgery and in post-anesthetic care unit

  17. Clara cell secretory protein-16 level

    biological indices, result from blood samples

    Measured: before surgery, before the end of surgery and in post-anesthetic care unit

  18. soluble receptor for advanced glycation end product level

    biological indices, result from blood samples

    Measured: before surgery, before the end of surgery and in post-anesthetic care unit

  19. angiopoietin-2 level

    biological indices, result from blood samples

    Measured: before surgery, before the end of surgery and in post-anesthetic care unit

  20. plasminogen activator inhibitor-1

    biological indices, result from blood samples

    Measured: before surgery, before the end of surgery and in post-anesthetic care unit

  21. mortality rates

    mortality rates

    Measured: at 90 days after surgery

  22. complications

    including postoperative respiratory and non-respiratory complications

    Measured: at 30 days after surgery

  23. vital signs

    vital signs will be recorded at any key time points from admission to operating room to extubation

    Measured: admission to operating room to day 7 after surgery, and the day of discharge

  24. Vasoactive medications dosages

    Vasoactive medications includes norepinephrine, phenylephrine, ephedrine

    Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2023
  2. Study start30 Nov 2023
  3. Primary completion18 Nov 2024
  4. Study completion9 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06150079
Sponsor's protocol ID
B2023-334R
Status last verified
Jul 2025
First submitted
11 Nov 2023
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.

    PubMed 21045639

  • Hegeman MA, Hemmes SN, Kuipers MT, Bos LD, Jongsma G, Roelofs JJ, van der Sluijs KF, Juffermans NP, Vroom MB, Schultz MJ. The extent of ventilator-induced lung injury in mice partly depends on duration of mechanical ventilation. Crit Care Res Pract. 2013;2013:435236. doi: 10.1155/2013/435236. Epub 2013 Apr 17.

    PubMed 23691294

  • Tusman G, Bohm SH, Warner DO, Sprung J. Atelectasis and perioperative pulmonary complications in high-risk patients. Curr Opin Anaesthesiol. 2012 Feb;25(1):1-10. doi: 10.1097/ACO.0b013e32834dd1eb.

    PubMed 22113182

  • Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.

    PubMed 27829093

  • Ferrando C, Soro M, Unzueta C, Suarez-Sipmann F, Canet J, Librero J, Pozo N, Peiro S, Llombart A, Leon I, India I, Aldecoa C, Diaz-Cambronero O, Pestana D, Redondo FJ, Garutti I, Balust J, Garcia JI, Ibanez M, Granell M, Rodriguez A, Gallego L, de la Matta M, Gonzalez R, Brunelli A, Garcia J, Rovira L, Barrios F, Torres V, Hernandez S, Gracia E, Gine M, Garcia M, Garcia N, Miguel L, Sanchez S, Pineiro P, Pujol R, Garcia-Del-Valle S, Valdivia J, Hernandez MJ, Padron O, Colas A, Puig J, Azparren G, Tusman G, Villar J, Belda J; Individualized PeRioperative Open-lung VEntilation (iPROVE) Network. Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial. Lancet Respir Med. 2018 Mar;6(3):193-203. doi: 10.1016/S2213-2600(18)30024-9. Epub 2018 Jan 19.

    PubMed 29371130

  • Zhang C, Xu F, Li W, Tong X, Xia R, Wang W, Du J, Shi X. Driving Pressure-Guided Individualized Positive End-Expiratory Pressure in Abdominal Surgery: A Randomized Controlled Trial. Anesth Analg. 2021 Nov 1;133(5):1197-1205. doi: 10.1213/ANE.0000000000005575.

    PubMed 34125080

  • Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.

    PubMed 24467647

  • Fernandez-Bustamante A, Sprung J, Parker RA, Bartels K, Weingarten TN, Kosour C, Thompson BT, Vidal Melo MF. Individualized PEEP to optimise respiratory mechanics during abdominal surgery: a pilot randomised controlled trial. Br J Anaesth. 2020 Sep;125(3):383-392. doi: 10.1016/j.bja.2020.06.030. Epub 2020 Jul 16.

    PubMed 32682559

  • Cammarota G, Lauro G, Sguazzotti I, Mariano I, Perucca R, Messina A, Zanoni M, Garofalo E, Bruni A, Della Corte F, Navalesi P, Bignami E, Vaschetto R, Mojoli F. Esophageal Pressure Versus Gas Exchange to Set PEEP During Intraoperative Ventilation. Respir Care. 2020 May;65(5):625-635. doi: 10.4187/respcare.07238.

    PubMed 32345760

  • Zhong J, Xu P, Zhou X, Zou K, Yu J, Liu Y, Zhu M, Wei M, Yang H, Miao C. Effect of intraoperative oesophageal pressure-guided PEEP on postoperative pulmonary complications in elderly patients undergoing major laparoscopic surgery: study protocol for a multicentre randomised controlled clinical trial in China. BMJ Open. 2025 Aug 13;15(8):e096219. doi: 10.1136/bmjopen-2024-096219.

    PubMed 40812804

Questions about this trial

What is this clinical trial studying?

A study testing Pes-Guided PEEP titration in people with Postoperative Pulmonary Complications and Positive End-expiratory Pressure, run by Shanghai Zhongshan Hospital at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative pulmonary complications (time frame: within 7 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06150079, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in