Comparing Valve-regulated Pleural Drainage to Traditional Closed Chest Tube Drainage

NCT06410716 | Recruiting

• 1 other identifier: TDRWR-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Lung Cancer

Keywords

lung cancer; thoracic drainage system

Outcome Measures

Primary Outcomes (1)

• Postoperative drainage duration

  Postoperative drainage duration

  From surgery to chest tube removal

Secondary Outcomes (2)

• Numerical Rating Scale (NRS) cores

  From surgery to chest tube removal

• Postoperative oxyhemoglobin saturation (SpO2)

  From surgery to chest tube removal

Study Arms (2)

Valve-regulated pleural drainage system

EXPERIMENTAL

Patients using valve-regulated pleural drainage system.

Device: Valve-regulated pleural drainage system

Closed chest tube drainage

NO INTERVENTION

Patients using traditional closed chest tube drainage

Interventions

Valve-regulated pleural drainage system DEVICE

Patients using valve-regulated pleural drainage system (Ningbo Xinyue Medical Technology Co., Ltd., model AFG31-1) postoperatively.

Valve-regulated pleural drainage system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who accepted thoracoscopic lobectomy and lymph node dissection;
• Written consent is able to obtained.

You may not qualify if:

• Pregnant or lactating women;
• Patients with significant dysfunction of organs such as the heart, liver, or kidneys;
• Patients with pleural effusion or pneumothorax preoperatively.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Ningbo Xinyue Medical Technology Co., LTD: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Lei Liu, MD

CONTACT

18105369996; liulei12130@pumch.cn

Xuehan Gao, MD

CONTACT

18801341299; gaoxh1299@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random number table

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: April 20, 2024
• Primary Completion: October 1, 2024
• Study Completion: April 30, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)