Comparing Valve-regulated Pleural Drainage to Traditional Closed Chest Tube Drainage
NCT06410716 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2024-05-17
Summary
Thoracic drainage is an important adjunctive treatment following thoracic surgery, primarily aimed at removing postoperative blood, air, and exudate from the thoracic cavity. It helps maintain negative pressure in the thoracic cavity, promotes full lung expansion, and prevents pulmonary complications, especially atelectasis. Traditional closed thoracic drainage methods have many limitations. Dry valve-regulated pleural drainage system overcome these limitations. Preliminary studies have shown that they offer advantages such as high safety, ease of operation, and reduced nursing burden. The investigators plan to conduct a real-world randomized controlled study comparing the clinical efficacy of dry valve-regulated pleural drainage system with traditional water-sealed drainage systems, both of which are commonly used in clinical practice. The goal of this study is to provide solid evidence based on evidence-based medicine for the optimal practice of thoracic drainage, further optimize post-thoracic surgery drainage treatment protocols, enhance the quality and efficiency of patient care, and provide scientific evidence for the development or updating of relevant clinical guidelines.
Conditions
Interventions
- DEVICE
-
Valve-regulated pleural drainage system
Patients using valve-regulated pleural drainage system (Ningbo Xinyue Medical Technology Co., Ltd., model AFG31-1) postoperatively.
Sponsors & Collaborators
-
Ningbo Xinyue Medical Technology Co., LTD
collaborator UNKNOWN -
Peking Union Medical College Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-20
- Primary Completion
- 2024-10-01
- Completion
- 2025-04-30
Countries
- China
Study Locations
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