- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07372378
Association of Different Tidal Volumes and Postoperative Pulmonary Complications
Association of Various Introperative Tidal Volumes and Postoperative Pulmonary Complications After Video-assisted Thoracic Surgery
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hui Ye, M.D.
- Phone Number: 8615267048716
- Email: yehui@zju.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pulmonary Complications (PPCs)
Time Frame: 1-7 days after surgery
|
Postoperative Pulmonary Complications (PPCs): Incidence of any PPC within 7 days postoperatively
|
1-7 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of hypoxemia
Time Frame: during surgery
|
Incidence of hypoxemia: Occurring before the end of surgery
|
during surgery
|
|
Length of Hospital Stay
Time Frame: through study completion, an average of 1 year
|
Length of Hospital Stay
|
through study completion, an average of 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative Oxygenation Index
Time Frame: during surgery
|
Intraoperative Oxygenation Index
|
during surgery
|
|
Intraoperative Lung Compliance
Time Frame: during surgery
|
Intraoperative Lung Compliance
|
during surgery
|
|
Intraoperative Driving Pressure
Time Frame: during surgery
|
Intraoperative Driving Pressure
|
during surgery
|
|
Intraoperative Dead Space to Tidal Volume Ratio (Vd/Vt)
Time Frame: during surgery
|
Intraoperative Dead Space to Tidal Volume Ratio (Vd/Vt)
|
during surgery
|
|
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.
|
At the end of surgery
|
|
In-hospital mortality
Time Frame: through study completion, an average of 1 year
|
In-hospital mortality
|
through study completion, an average of 1 year
|
|
28-day mortality
Time Frame: 28 day postoperatively
|
28-day mortality
|
28 day postoperatively
|
|
90-day mortality
Time Frame: 90 day postoperatively
|
90-day mortality
|
90 day postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Signs and Symptoms, Respiratory
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Hypoxia
- Carcinoma, Non-Small-Cell Lung
Other Study ID Numbers
- VolumePPC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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