Individualized Open Lung Ventilation and Postoperative Pulmonary Complications in Thoracic Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAerospace Center Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Lung-Protective Ventilation

    Procedure/Surgery

    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.

  • Individualized Open Lung Ventilation

    Procedure/Surgery

    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 ventilation.

Treatment groups

352 Participants
are divided into 2 treatment groups
Group A: Standard Lung-Protective Ventilation GroupActive comparator 1 intervention
Group B: Individualized Open Lung Ventilation GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of postoperative pulmonary complications within 7 days

Postoperative pulmonary complications (PPCs) occurring within 7 days after surgery, defined according to pre-specified criteria, including pneumonia, atelectasis requiring therapeutic intervention, acute respiratory distress syndrome (ARDS), respiratory failure requiring noninvasive or invasive mechanical ventilation, reintubation, or mechanical ventilation lasting longer than 48 hours.

Time frame
Within 7 days after surgery

Secondary outcomes

1

Incidence of secondary postoperative pulmonary complications within 30 days

Secondary postoperative pulmonary complications occurring within 30 days after surgery, including mild atelectasis, pleural effusion, bronchospasm, prolonged air leak, and other pulmonary complications not meeting the criteria for primary postoperative pulmonary complications.

Time frame
Within 30 days after surgery
2

Intraoperative Driving Pressure

Driving pressure is calculated as the difference between Plateau Pressure and Positive End-Expiratory Pressure. Lower driving pressure indicates lung-protective ventilation. Assessments are performed at 5 predefined time points: T1 (TLV baseline after positioning), T2 (OLV 30 minutes), T3 (OLV 60 minutes), T4 (during resection), and T5 (within 15 minutes of TLV restoration).

Time frame
From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.
3

Incidence of non-pulmonary postoperative complications

Postoperative non-pulmonary complications within 30 days after surgery, including cardiovascular, neurological, gastrointestinal, urinary, and wound-related complications.

Time frame
Within 30 days after surgery
4

Intraoperative Dynamic Compliance

Dynamic compliance is measured as Tidal Volume divided by (Peak Pressure - PEEP). Higher compliance suggests better lung mechanics. Data is collected at T1 (TLV baseline), T2 (OLV 30 minutes), T3 (OLV 60 minutes), T4 (during resection), and T5 (within 15 minutes of TLV restoration).

Time frame
From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.

Other outcomes

Sponsors and contacts

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