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| Name | Class |
|---|---|
| Shanghai Geriatric Medical Center | OTHER |
| Zhongshan Hospital (Xiamen), Fudan University | OTHER |
| Fudan University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pulmonary complications | the incidence of postoperative pulmonary complications | within 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| airway peak pressure (cmH2O) | intraoperative mechanical ventilation parameters | intraoperative |
| plateau pressure | intraoperative mechanical ventilation parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Changhong Miao | Zhongshang Hospital Fudan University | Study Director |
| Jing Zhong | Zhongshang Hospital Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Shanghai | 200032 | China | |||
| Fudan University Shanghai Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21045639 | Background | 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. | |
| 23691294 | Background | 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. |
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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.
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| intraoperative |
| positive end-expiratory pressure | intraoperative mechanical ventilation parameters | intraoperative |
| esophageal pressure (Pes) | a classical and most widely used marker of pleural pressure which is usually measured by air-filled balloons | intraoperative |
| driving pressure (cmH2O) | intraoperative mechanical ventilation parameters | intraoperative |
| transpulmonary pressure (PL) | equal to the difference between alveolar pressure and pleural pressure | intraoperative |
| dynamic lung compliance (mL/cmH20) | Cdyn = Vt/(Ppeak - PEEP) | intraoperative |
| static compliance (mL/cmH20) | pulmonary compliance measured at a fixed volume with no airflow and fully relaxed muscles. static compliance = VT / (Pplat - PEEP) | intraoperative |
| 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 | before surgery, intraoperative, and in post-anesthetic care unit |
| non-respiratory complications | the incidence of stroke, myocardial infarction, acute renal failure, DIC, SIRS, sepsis, septic shock, wound infection | within 7 days after surgery |
| QoR-15 scores | early quality of recovery | day 1 and day 7 after surgery, the day of discharge |
| unplanned reintubation | the incidence of unplanned reintubation | day 1 to day 7 after surgery |
| unplanned transfer to the ICU | the incidence of unplanned transfer to the ICU | day 1 to day 7 after surgery |
| duration of ICU stay | duration of ICU stay | day 1 after surgery to the day of discharge, assessed up to 90 days |
| length of hospital stay | 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 |
| Interleukin-6 level | 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 | 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 | biological indices, result from blood samples | before surgery, before the end of surgery and in post-anesthetic care unit |
| angiopoietin-2 level | biological indices, result from blood samples | before surgery, before the end of surgery and in post-anesthetic care unit |
| plasminogen activator inhibitor-1 | biological indices, result from blood samples | before surgery, before the end of surgery and in post-anesthetic care unit |
| mortality rates | mortality rates | at 90 days after surgery |
| complications | including postoperative respiratory and non-respiratory complications | at 30 days after surgery |
| vital signs | 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 |
| Vasoactive medications dosages | Vasoactive medications includes norepinephrine, phenylephrine, ephedrine | intraoperative |
| Shanghai |
| China |
| Shanghai Geriatric Medical Center | Shanghai | China |
| Zhongshan Hospital (Xiamen), Fudan University | Xiamen | China |
| 22113182 | 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. |
| 27829093 | Background | 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. |
| 29371130 | 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. |
| 34125080 | 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. |
| 24467647 | 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. |
| 32682559 | 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. |
| 32345760 | 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. |
| 40812804 | Derived | 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. |