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NCT Number: NCT07372378

Association of Different Tidal Volumes and Postoperative Pulmonary Complications

The incidence of lung cancer in China is increasing year by year. Currently, the treatment primarily based on video-assisted thoracoscopic surgery (VATS) is still considered the optimal approach for early-stage non-small cell lung cancer. The widespread application of traditional one-lung ventilation (OLV) technology not only achieves effective lung isolation, but also facilitates exposure of the surgical field during thoracoscopic surgery, making it more convenient for surgeons to operate. However, the occurrence of hypoxemia during one-lung ventilation may pose a risk to patient safety.

One-lung ventilation can lead to increased intrapulmonary shunt, ventilation/perfusion (V/Q) mismatch, and ischemic-hypoxic lung injury. Hypoxemia is the major problem during one-lung ventilation. Postoperative pulmonary complications (PPCs) are among the major complications following thoracic and general anesthesia surgeries, including atelectasis, pneumonia, and respiratory failure, which significantly prolong hospital stay and increase mortality.

Low tidal volume lung-protective ventilation strategies have been widely implemented. Additionally, permissive hypercapnia, reducing peak airway pressure to minimize barotrauma, and decreasing FiO₂ all help reduce pulmonary complications.Recently, researchers have focused on optimizing ventilation strategies during OLV, such as using PEEP or low VT ventilation alone or in combination, or exploring different combinations of tidal volume and respiratory frequency under consistent minute ventilation (VE), aiming to balance lung protection and oxygenation, reduce complications, and improve patient outcomes.

However, to date, there is still no gold standard tidal volume ventilation strategy for reducing pulmonary complications in patients undergoing lung resection.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 50 years.
  • ASA physical status I-II.
  • The cardiopulmonary and other vital organ functions are basically normal, and the patient is able to tolerate surgery.
  • Ariscat score > 26.
  • Informed consent has been obtained.

Exclusion criteria

  • Patients who refuse to participate in the clinical trial, or have cognitive impairment or impaired ability to understand and express themselves.
  • ASA physical status ≥ III.
  • Patients with congestive heart failure, severe aortic stenosis, or extensive pleural adhesions.
  • Patients with severe psychiatric disorders or allergy to anesthesia-related medications.
  • Patients with severe organ dysfunction such as the liver or kidney dysfunction.

Treatment and study plan

Primary outcomes

  1. Postoperative Pulmonary Complications (PPCs)

    Time frame: 1-7 days after surgery

    Postoperative Pulmonary Complications (PPCs): Incidence of any PPC within 7 days postoperatively

Secondary outcomes

  1. Incidence of hypoxemia

    Time frame: during surgery

    Incidence of hypoxemia: Occurring before the end of surgery

  2. Length of Hospital Stay

    Time frame: through study completion, an average of 1 year

    Length of Hospital Stay

Other outcomes

  1. Intraoperative Oxygenation Index

    Time frame: during surgery

    Intraoperative Oxygenation Index

  2. Intraoperative Lung Compliance

    Time frame: during surgery

    Intraoperative Lung Compliance

  3. Intraoperative Driving Pressure

    Time frame: during surgery

    Intraoperative Driving Pressure

  4. Intraoperative Dead Space to Tidal Volume Ratio (Vd/Vt)

    Time frame: during surgery

    Intraoperative Dead Space to Tidal Volume Ratio (Vd/Vt)

  5. Surgeon Satisfaction

    Time frame: At the end of surgery

    The degree of surgeon satisfaction regarding the performance, effectiveness, and experience of a procedure. A 10-point scale is used, 0 indicates complete dissatisfaction and 10 indicates complete satisfaction.

  6. In-hospital mortality

    Time frame: through study completion, an average of 1 year

    In-hospital mortality

  7. 28-day mortality

    Time frame: 28 day postoperatively

    28-day mortality

  8. 90-day mortality

    Time frame: 90 day postoperatively

    90-day mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Ye, M.D.

CONTACT

[email protected]

8615267048716

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Association of Various Introperative Tidal Volumes and Postoperative Pulmonary Complications After Video-assisted Thoracic Surgery

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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