Individualized PEEP Titration on Postoperative Pulmonary Complications

Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150079
• Other study ID #: B2023-334R
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Shanghai Zhongshan Hospital
• Contact: Changhong Miao
• Phone: +8613681975062
• Email: miao.changhong[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 laparoscopic surgery.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: August 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged 65 years or older, of any gender.

2. Laparoscopic surgery under general anesthesia.

3. Anticipated duration of surgery = 2 hours.

4. Willingness to sign informed consent or provide a legally authorized representative.

Exclusion Criteria:

1. Obesity, defined as 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, or systemic corticosteroid treatment for acute COPD exacerbations.

4. Severe pulmonary arterial hypertension, defined as pulmonary artery systolic pressure > 40 mmHg.

5. 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.

6. Severe cardiac disease (NYHA class III or IV, acute coronary syndrome, sustained ventricular tachyarrhythmias, unable to achieve > 4 METs).

7. Severe liver or renal dysfunction (Child-Pugh score 10-15, serum creatinine = 2 mg/dL, or patients requiring peritoneal dialysis or hemodialysis).

8. Neuromuscular disease (of any type).

9. History of bone marrow transplantation or recent use of immunosuppressive drugs (chemotherapy or radiotherapy within 2 months before surgery).

10. Mechanical ventilation duration > 30 minutes within the past 30 days (e.g., during surgery under general anesthesia).

11. Requirement for one-lung ventilation.

12. History of acute respiratory distress syndrome with potential need for prolonged postoperative mechanical ventilation.

13. Planned re-intubation after surgery.

14. Pregnancy (excluded by medical history and/or laboratory tests).

15. Brain injury or tumor.

16. Requirement for prone or lateral position during surgery.

17. Severe esophagogastric varices.

18. Enrollment in other interventional studies or refusal to sign informed consent.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai
China	Shanghai Geriatric Medical Center	Shanghai
China	Zhongshan Hospital (Xiamen), Fudan University	Xiamen
Switzerland	University Hospital, Basel, Switzerland	Basel

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Fudan University, Shanghai Geriatric Medical Center, University Hospital, Basel, Switzerland, Zhongshan Hospital (Xiamen), Fudan University

Countries where clinical trial is conducted

China,  Switzerland, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pulmonary complications	the incidence of postoperative pulmonary complications	day 1 to day 7 after surgery, and day 30 after surgery
Secondary	airway peak pressure (cmH2O)	intraoperative mechanical ventilation parameters	intraoperative
Secondary	driving pressure (cmH2O)	intraoperative mechanical ventilation parameters	intraoperative
Secondary	Vt (ml)	tidal volume	intraoperative
Secondary	dynamic lung compliance (mL/cmH20)	Cdyn = Vt/(Ppeak - PEEP)	intraoperative
Secondary	PaCO2 (mmHg)	measured the partial pressure of carbon dioxide in arterial blood	intraoperative
Secondary	EtCO2 (mmHg)	End-tidal carbon dioxide	intraoperative
Secondary	PaO2/FiO2 ratio	the ratio of partial pressure of oxygen in arterial blood (PaO2) to the fraction of inspiratory oxygen concentration (FiO2)	intraoperative
Secondary	PaO2 (mmHg)	partial pressure of oxygen in arterial blood	intraoperative
Secondary	non-respiratory complications	the incidence of stroke, myocardial infarction, acute renal failure, DIC, SIRS, sepsis, septic shock, wound infection	day 1 to day 7 after surgery, and day 30 after surgery
Secondary	QoR-15 scores	early quality of recovery	day 1 and day 3 after surgery, the day of discharge, and day 30 after surgery
Secondary	unplanned reintubation	the incidence of unplanned reintubation	day 1 to day 7 after surgery
Secondary	unplanned transfer to the ICU	the incidence of unplanned transfer to the ICU	day 1 to day 7 after surgery
Secondary	duration of ICU stay	duration of ICU stay	day 1 after surgery to the day of discharge, assessed up to 90 days
Secondary	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
Secondary	mortality rates	mortality rates	at 30 and 90 days