Individualized Open Lung Ventilation and Postoperative Pulmonary Complications in Thoracic Surgery

Official title

Effect of Individualized Versus Standardized Open-Lung Ventilation on Postoperative Pulmonary Complications in Thoracic Surgery: A Randomized Controlled Trial

Overview

This prospective, single-center, randomized controlled trial aims to evaluate the efficacy of an intraoperative "Individualized Open Lung Ventilation" strategy compared to a standard lung-protective ventilation strategy in patients undergoing thoracic surgery. One-lung ventilation (OLV) is essential for thoracic surgery but can cause lung injury. While standard care often uses fixed ventilation parameters, this study investigates whether personalizing Positive End-Expiratory Pressure (PEEP) to achieve the lowest driving pressure can reduce the incidence of postoperative pulmonary complications (PPCs) within 7 days after surgery.

Detailed description

Background: Postoperative pulmonary complications (PPCs) are a major cause of morbidity following thoracic surgery. One-lung ventilation (OLV), while necessary for surgical exposure, induces ischemia-reperfusion injury and mechanical stress. Current standard lung-protective ventilation (LPV) strategies typically employ low tidal volumes with a fixed Positive End-Expiratory Pressure (PEEP). However, fixed parameters may not account for individual variations in lung compliance and mechanics. This study hypothesizes that an individualized open lung approach, guided by driving pressure, will optimize lung mechanics and reduce clinical complications.

Study Design: This is a prospective, randomized controlled trial conducted at Aerospace Center Hospital. Eligible patients aged 18-75 undergoing elective video-assisted thoracic surgery (VATS) with an expected OLV duration of \>1 hour will be enrolled.

Intervention Groups: Participants are randomized (1:1) into two groups:

Control Group (Standard Strategy): Patients receive volume-controlled ventilation during OLV with a tidal volume of 6 mL/kg predicted body weight (PBW) and a fixed PEEP of 5 cmH2O. No routine lung recruitment maneuvers are performed.

Experimental Group (Individualized Strategy): Patients receive a tidal volume of 4-6 mL/kg PBW. Upon initiating OLV, a lung recruitment maneuver is performed (PEEP increased to 10 cmH2O). Subsequently, a decremental PEEP trial is conducted (starting at 10 cmH2O and decreasing by 1 cmH2O steps) to identify the optimal PEEP level that produces the lowest driving pressure. This optimal PEEP is maintained for the duration of OLV.

Outcomes: The primary outcome is the incidence of defined Postoperative Pulmonary Complications (PPCs) within 7 days post-surgery, including pneumonia, atelectasis, ARDS, respiratory failure, and re-intubation. Secondary outcomes include intraoperative respiratory mechanics (driving pressure, compliance, oxygenation index), length of hospital stay, and other system complications.

Interventions

• Procedure Standard Lung-Protective Ventilation
  Standard lung-protective ventilation is applied during one-lung ventilation. Ventilation parameters include a tidal volume of 6 mL/kg predicted body weight and a fixed positive end-expiratory pressure (PEEP) of 5 cmH2O throughout one-lung ventilation. No routine recruitment maneuver is performed during one-lung ventilation. At the end of one-lung ventilation, a standardized lung recruitment maneuver is applied before resuming two-lung ventilation.
• Procedure Individualized Open Lung Ventilation
  Individualized open lung ventilation is applied during one-lung ventilation. Tidal volume is set at 4-6 mL/kg predicted body weight. After lung recruitment, a decremental PEEP trial is performed starting from 10 cmH2O, with PEEP reduced stepwise to identify the level associated with the lowest driving pressure. The selected PEEP is maintained throughout one-lung ventilation. A standardized lung recruitment maneuver is applied at the end of one-lung ventilation before resuming two-lung ventilatio

Primary outcome measures

• Incidence of postoperative pulmonary complications within 7 days [Time frame: Within 7 days after surgery]

Secondary outcome measures (12)

• Incidence of secondary postoperative pulmonary complications within 30 days [Time frame: Within 30 days after surgery]
• Intraoperative Driving Pressure [Time frame: From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.]
• Incidence of non-pulmonary postoperative complications [Time frame: Within 30 days after surgery]
• Intraoperative Dynamic Compliance [Time frame: From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.]
• Intraoperative Peak Airway Pressure [Time frame: From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.]
• Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen Ratio [Time frame: From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.]
• Hospital Length of Stay [Time frame: Participants will be followed for the duration of hospital stay, an average of 7-9 days.]
• Incidence of ICU Admission [Time frame: From date of surgery until date of discharge, assessed up to 30 days]
• 30-Day Mortality [Time frame: 30 days post-surgery]
• Incidence of Intraoperative Hypotension [Time frame: From the start of anesthesia induction until the end of surgery.]
• Incidence of Pneumothorax [Time frame: Within 7 days after surgery.]
• Partial Pressure of Carbon Dioxide [Time frame: From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.]

Eligibility criteria

Inclusion criteria

• Age 18 to 75 years.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Body mass index between 18 and 30 kg/m².
• Scheduled for elective video-assisted thoracoscopic surgery (VATS).
• Expected duration of one-lung ventilation longer than 1 hour.
• Able to understand the study procedures and provide written informed consent.

Exclusion criteria

• Pregnancy or breastfeeding.
• Emergency surgery or reoperation.
• History of severe pulmonary disease, including chronic obstructive pulmonary disease, pulmonary fibrosis, severe emphysema, pulmonary bullae, pneumothorax, or uncontrolled asthma.
• History of heart failure or coronary artery disease.
• Previous thoracic surgery or mechanical ventilation within 1 month before surgery.
• Planned postoperative mechanical ventilation.
• Bilateral thoracic surgery.
• Participation in another interventional clinical trial.
• Conversion to open thoracotomy during surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

China · 1 center

• Aerospace Center Hospital — Beijing

Publications

• Caplan JP, Chang G. Refeeding syndrome as an iatrogenic cause of delirium: a retrospective pilot study. Psychosomatics. 2010 Sep-Oct;51(5):419-24. doi: 10.1176/appi.psy.51.5.419. PMID 20833941
• Dulski J, Middlebrooks EH, Wszolek ZK. Novel Neuroimaging Pattern in POLR3A-Related Disorder on 7T MRI. Neurol Genet. 2024 Jan 10;10(1):e200125. doi: 10.1212/NXG.0000000000200125. eCollection 2024 Feb. No abstract available. PMID 38213753
• Zaitsu M, Kono K, Hosokawa Y, Miyamoto M, Nanishi K, Okawa S, Niki S, Takahashi K, Yoshihara S, Kobashi G, Tabuchi T. Maternal heated tobacco product use during pregnancy and allergy in offspring. Allergy. 2023 Apr;78(4):1104-1112. doi: 10.1111/all.15536. Epub 2022 Oct 11. PMID 36176042

Identifiers

NCT: NCT07387822 · XYin-Trial-2026-01-08

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗