NCT07387822

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Feb 2026May 2026

First Submitted

Initial submission to the registry

January 8, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2026

Expected
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 8, 2026

Last Update Submit

January 30, 2026

Conditions

One-lung Ventilation (OLV)Thoracic Surgery, Video AssistedPostoperative Pulmonary Complications (PPCs)

Keywords

Individualized Open Lung VentilationDriving PressurePEEP TitrationLung Recruitment ManeuverLung Protective VentilationVideo-Assisted Thoracic Surgery

Outcome Measures

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.

    Within 7 days after surgery

Secondary Outcomes (15)

  • Incidence of secondary postoperative pulmonary complications within 30 days

    Within 30 days after surgery

  • Intraoperative Driving Pressure

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

  • Incidence of non-pulmonary postoperative complications

    Within 30 days after surgery

  • Intraoperative Dynamic Compliance

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

  • Intraoperative Peak Airway Pressure

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

  • +10 more secondary outcomes

Study Arms (2)

Standard Lung-Protective Ventilation Group

ACTIVE COMPARATOR
Procedure: Standard Lung-Protective Ventilation

Individualized Open Lung Ventilation Group

EXPERIMENTAL
Procedure: Individualized Open Lung Ventilation

Interventions

Standard Lung-Protective VentilationPROCEDURE

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.

Standard Lung-Protective Ventilation Group
Individualized Open Lung VentilationPROCEDURE

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.

Individualized Open Lung Ventilation Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aerospace Center Hospital

Beijing, China

Location

Related Publications (3)

  • 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: 20833941RESULT

  • 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: 38213753RESULT

  • 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: 36176042RESULT

Study Officials

  • Xiangli Zheng

    Aerospace Center Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinrui Yin

CONTACT

+86-13029315156ahywvn@pku.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 8, 2026

First Posted

February 4, 2026

Study Start

February 10, 2026

Primary Completion

April 10, 2026

Study Completion (Estimated)

May 10, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Locations

CN(1)