Individualized PEEP Titration on Postoperative Pulmonary Complications

NCT06150079 | Completed DMC

• 1 other identifier: B2023-334R
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• postoperative pulmonary complications

  the incidence of postoperative pulmonary complications

  within 7 days after surgery

Secondary Outcomes (24)

• airway peak pressure (cmH2O)

  intraoperative

• plateau pressure

  intraoperative

• positive end-expiratory pressure

  intraoperative

• esophageal pressure (Pes)

  intraoperative

• driving pressure (cmH2O)

  intraoperative

Study Arms (2)

Control Group

NO INTERVENTION

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.

Pes-Guided Group

EXPERIMENTAL

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

Interventions

Pes-Guided PEEP titration PROCEDURE

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.

Pes-Guided Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Shanghai Geriatric Medical Center: collaborator
• Zhongshan Hospital (Xiamen), Fudan University: collaborator
• Fudan University: collaborator

Study Sites (4)

180 Fenglin Road

Shanghai, 200032, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Shanghai Geriatric Medical Center

Shanghai, China

Location

Zhongshan Hospital (Xiamen), Fudan University

Xiamen, China

Location

Related Publications (10)

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• 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.

  PMID: 23691294 BACKGROUND

• 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.

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• 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.

  PMID: 27829093 BACKGROUND

• 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.

  PMID: 29371130 BACKGROUND

• 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.

  PMID: 34125080 BACKGROUND

• 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.

  PMID: 24467647 BACKGROUND

• 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.

  PMID: 32682559 BACKGROUND

• 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.

  PMID: 32345760 BACKGROUND

• 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.

  PMID: 40812804 DERIVED

Study Officials

• Changhong Miao

  Zhongshang Hospital Fudan University

  STUDY DIRECTOR

• Jing Zhong

  Zhongshang Hospital Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 29, 2023
• Study Start: November 30, 2023
• Primary Completion: November 18, 2024
• Study Completion: February 9, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (4)