Association of Different Tidal Volumes and Postoperative Pulmonary Complications

NCT07372378 | Not Yet Recruiting

• 1 other identifier: VolumePPC
• Study Type: observational
• Target: 650
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypoxemia During Surgery; Pulmonary Complications; Thoracic Surgery, Video Assisted; One Lung Ventillation (OLV); Lung Cancer (Non-Small Cell)

Keywords

pulmonary complications; hypoxemia; video-assisted thoracic surgery; one lung ventilation

Outcome Measures

Primary Outcomes (1)

• Postoperative Pulmonary Complications (PPCs)

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

  1-7 days after surgery

Secondary Outcomes (2)

• Incidence of hypoxemia

  during surgery

• Length of Hospital Stay

  through study completion, an average of 1 year

Other Outcomes (8)

• Intraoperative Oxygenation Index

  during surgery

• Intraoperative Lung Compliance

  during surgery

• Intraoperative Driving Pressure

  during surgery

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing video-assisted lung surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Hypoxia

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hui Ye, M.D.

CONTACT

8615267048716; yehui@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 28, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 24, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share