Individualized PEEP Titration on Postoperative Pulmonary Complications
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 (PEEP Group), fixed PEEP of 3 cmH2O is applied throughout the procedure without lung recruitment maneuvers. While in the experimental group (Pes-Guided PEEP Group), continuous monitoring of end-expiratory esophageal pressure (Pes_ee) is conducted. PEEP is chosen to maintain a positive transpulmonary pressure at end-expiration (Ptp_ee = PEEP - Pes_ee) 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: PEEP 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_ee) is conducted. Fixed PEEP of 3 cmH2O is applied throughout the procedure without lung recruitment maneuvers. |
|
| Experimental: Pes-Guided PEEP Group (PEEPPtp) After endotracheal intubation, an esophageal balloon is placed and calibrated for accurate positioning and inflation pressure. Continuous monitoring of end-expiratory esophageal pressure (Pes_ee) 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 (Ptp_ee = PEEP - Pes_ee). 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 (Ptp_ee = PEEP - Pes_ee). Each PEEP titration should ensure adequate muscle relaxation, volume status, and hemodynamic stability.
|
Outcome Measures
Primary Outcome Measures
- postoperative pulmonary complications [day 1 to day 7 after surgery, and day 30 after surgery]
the incidence of postoperative pulmonary complications
Secondary Outcome Measures
- airway peak pressure (cmH2O) [intraoperative]
intraoperative mechanical ventilation parameters
- driving pressure (cmH2O) [intraoperative]
intraoperative mechanical ventilation parameters
- Vt (ml) [intraoperative]
tidal volume
- dynamic lung compliance (mL/cmH20) [intraoperative]
Cdyn = Vt/(Ppeak - PEEP)
- PaCO2 (mmHg) [intraoperative]
measured the partial pressure of carbon dioxide in arterial blood
- EtCO2 (mmHg) [intraoperative]
End-tidal carbon dioxide
- PaO2/FiO2 ratio [intraoperative]
the ratio of partial pressure of oxygen in arterial blood (PaO2) to the fraction of inspiratory oxygen concentration (FiO2)
- PaO2 (mmHg) [intraoperative]
partial pressure of oxygen in arterial blood
- non-respiratory complications [day 1 to day 7 after surgery, and day 30 after surgery]
the incidence of stroke, myocardial infarction, acute renal failure, DIC, SIRS, sepsis, septic shock, wound infection
- QoR-15 scores [day 1 and day 3 after surgery, the day of discharge, and day 30 after surgery]
early quality of recovery
- unplanned reintubation [day 1 to day 7 after surgery]
the incidence of unplanned reintubation
- unplanned transfer to the ICU [day 1 to day 7 after surgery]
the incidence of unplanned transfer to the ICU
- duration of ICU stay [day 1 after surgery to the day of discharge, assessed up to 90 days]
duration of ICU stay
- length of hospital stay [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
- mortality rates [at 30 and 90 days]
mortality rates
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients aged 65 years or older, of any gender.
-
Laparoscopic surgery under general anesthesia.
-
Anticipated duration of surgery ≥ 2 hours.
-
Willingness to sign informed consent or provide a legally authorized representative.
Exclusion Criteria:
-
Obesity, defined as 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, or systemic corticosteroid treatment for acute COPD exacerbations.
-
Severe pulmonary arterial hypertension, defined as pulmonary artery systolic pressure
40 mmHg.
-
Heart failure, ongoing hemodynamic instability, or severe shock (as 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 (NYHA class III or IV, acute coronary syndrome, sustained ventricular tachyarrhythmias, unable to achieve > 4 METs).
-
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 use of immunosuppressive drugs (chemotherapy or radiotherapy within 2 months before surgery).
-
Mechanical ventilation duration > 30 minutes within the past 30 days (e.g., during 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 180 Fenglin Road | Shanghai | China | 200032 |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
- Shanghai Geriatric Medical Center
- Zhongshan Hospital (Xiamen), Fudan University
- University Hospital, Basel, Switzerland
- Fudan University
Investigators
- Study Director: Changhong Miao, Zhongshang Hospital Fudan University
- Principal Investigator: Jing Zhong, Zhongshang Hospital Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- B2023-334R