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Not yet recruiting NCT07372378

Association of Different Tidal Volumes and Postoperative Pulmonary Complications

Observational Pulmonary Complications Hypoxemia During Surgery Thoracic Surgery, Video Assisted One Lung Ventillation (OLV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pulmonary Complications, Hypoxemia During Surgery, Thoracic Surgery, Video Assisted, One Lung Ventillation (OLV). Basic parameters: from 51 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Postoperative Pulmonary Complications (PPCs) [Time frame: 1-7 days after surgery]
Secondary outcome measures (2)
  • Incidence of hypoxemia [Time frame: during surgery]
  • Length of Hospital Stay [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07372378 · VolumePPC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗