Postoperative Pulmonary Complications (PPCs)NCT07387822
Individualized Open Lung Ventilation and Postoperative Pulmonary Complications in Thoracic Surgery
A study testing Standard Lung-Protective Ventilation and Individualized Open Lung Ventilation in people with Postoperative Pulmonary Complications (PPCs) and One-lung Ventilation (OLV), run by Aerospace Center Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pulmonary Complications (PPCs), One-lung Ventilation (OLV), Thoracic Surgery, Video Assisted
- What is being tested?
- Standard Lung-Protective Ventilation and Individualized Open Lung Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2026to 10 May 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Bilateral thoracic surgery.
- Participation in another interventional clinical trial.
- Conversion to open thoracotomy during surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Aerospace Center Hospital
Beijing
Xinrui Yin, +86-13029315156, ahywvn@pku.org.cn
About this study
Official title: Effect of Individualized Versus Standardized Open-Lung Ventilation on Postoperative Pulmonary Complications in Thoracic Surgery: A Randomized Controlled 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.
Read the 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.
- Conditions
- Postoperative Pulmonary Complications (PPCs), One-lung Ventilation (OLV), Thoracic Surgery, Video Assisted
- Being tested
- Standard Lung-Protective Ventilation, Individualized Open Lung Ventilation
- Keywords
- Individualized Open Lung Ventilation, Driving Pressure, PEEP Titration, Lung Recruitment Maneuver, Lung Protective Ventilation, Video-Assisted Thoracic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Lung-Protective VentilationProcedure or 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 VentilationProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Lung-Protective Ventilation Group | Active comparator | Not described Receives: Procedure: Standard Lung-Protective Ventilation |
| Individualized Open Lung Ventilation Group | Experimental | Not described Receives: Procedure: Individualized Open Lung Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days after surgery
Secondary outcomes (15)
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.
Measured: Within 30 days after surgery
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).
Measured: From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.
Incidence of non-pulmonary postoperative complications
Postoperative non-pulmonary complications within 30 days after surgery, including cardiovascular, neurological, gastrointestinal, urinary, and wound-related complications.
Measured: Within 30 days after surgery
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).
Measured: From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.
Intraoperative Peak Airway Pressure
The maximum pressure measured during the inspiratory phase of the mechanical ventilation cycle. Data is collected 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).
Measured: 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
Ratio of arterial oxygen partial pressure to fractional inspired oxygen, assessed by arterial blood gas analysis to evaluate oxygenation status. Assessments are performed at: T1 (TLV baseline), T2 (OLV 30 minutes), T3 (OLV 60 minutes), T4 (during resection), and T5 (within 15 minutes of TLV restoration).
Measured: From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.
Hospital Length of Stay
he total duration of hospital stay from admission to discharge.
Measured: Participants will be followed for the duration of hospital stay, an average of 7-9 days.
Incidence of ICU Admission
Number of participants requiring admission to the Intensive Care Unit after surgery.
Measured: From date of surgery until date of discharge, assessed up to 30 days
30-Day Mortality
All-cause mortality occurring within 30 days after surgery.
Measured: 30 days post-surgery
Incidence of Intraoperative Hypotension
Defined as a mean arterial pressure < 65 mmHg or a > 20% decrease from baseline requiring vasopressor support.
Measured: From the start of anesthesia induction until the end of surgery.
Incidence of Pneumothorax
Occurrence of pneumothorax detected postoperatively.
Measured: Within 7 days after surgery.
Partial Pressure of Carbon Dioxide
PaCO2 levels measured by arterial blood gas analysis. Measurements correspond to 5 time points: T1 (TLV baseline), T2 (OLV 30 minutes), T3 (OLV 60 minutes), T4 (during resection), and T5 (within 15 minutes of TLV restoration).
Measured: From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.
Arterial pH
Acid-base status assessed by arterial blood gas analysis. Measurements correspond to 5 time points: T1 (TLV baseline), T2 (OLV 30 minutes), T3 (OLV 60 minutes), T4 (during resection), and T5 (within 15 minutes of TLV restoration).
Measured: From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.
Mean Arterial Pressure
Average blood pressure in an individual during a single cardiac cycle. Data is recorded at: T1 (TLV baseline), T2 (OLV 30 minutes), T3 (OLV 60 minutes), T4 (during resection), and T5 (within 15 minutes of TLV restoration).
Measured: From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.
Heart Rate
Frequency of the cardiac cycle measured in beats per minute. Data is recorded at: T1 (TLV baseline), T2 (OLV 30 minutes), T3 (OLV 60 minutes), T4 (during resection), and T5 (within 15 minutes of TLV restoration).
Measured: From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion10 Apr 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary Complications (PPCs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aerospace Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinrui Yin, Aerospace Center Hospital
- Investigators
- Xiangli Zheng, Principal investigator, Aerospace Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387822
- Sponsor's protocol ID
- XYin-Trial-2026-01-08
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 20833941Dulski 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.
PubMed 38213753Zaitsu 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.
PubMed 36176042