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

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06410716 on ClinicalTrials.gov