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

NCT ID: NCT06410716

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2025-04-30

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.

Detailed Description

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. In traditional closed thoracic drainage methods, a closed drainage bottle is connected by a water-sealed tube, utilizing the pressure gradient formed by the gas-liquid interface to achieve drainage. The entire process demands high requirements for medical staff, requiring regular checks for abnormal drainage fluid, observing pressure fluctuations, and adjusting the position of the drainage bottle. This process is not only cumbersome but also carries risks of infection, drainage obstruction, and water seal fluid backflow due to operational errors.

To overcome the limitations of traditional closed drainage methods, dry valve-regulated pleural drainage systems have emerged. These devices employ a one-way valve mechanism, eliminating the need for traditional water seals and fundamentally eliminating the need for water level monitoring and maintenance of drainage bottles, while reducing the potential for mechanical failures and operational errors. They exhibit significant advantages in enhancing safety, simplifying operational procedures, and reducing nursing burdens. Patients can move more freely without worrying about water seal leakage, which is crucial for early postoperative recovery.

Preliminary prospective small-sample studies have found that compared to traditional water-sealed drainage systems, dry valve-regulated drainage devices not only significantly shorten drainage time but also reduce the need for medical staff monitoring and operation, while lowering the risk of patient pulmonary air leakage and postoperative pneumothorax. However, existing evidence mainly comes from limited hospitals and small-sample studies, lacking large-scale research to support their widespread clinical application.

Based on this, the investigators plan to conduct a real-world randomized controlled study. The study will include patients undergoing lobectomy and lymph node dissection, and different drainage methods will be randomly assigned for research. The study will compare the effects of the two thoracic drainage methods on key clinical indicators such as postoperative drainage time, drainage volume, oxyhemoglobin saturation, early postoperative activity, patient comfort during recovery, and postoperative complications. Through scientific research design and statistical analysis, 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, and enhance the quality and efficiency of patient care.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Valve-regulated pleural drainage system

Patients using valve-regulated pleural drainage system.

Group Type: EXPERIMENTAL

Valve-regulated pleural drainage system

Intervention Type: DEVICE

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

Closed chest tube drainage

Patients using traditional closed chest tube drainage

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Valve-regulated pleural drainage system

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients who accepted thoracoscopic lobectomy and lymph node dissection;

2. Written consent is able to obtained.

Exclusion Criteria

1. Pregnant or lactating women;

2. Patients with significant dysfunction of organs such as the heart, liver, or kidneys;

3. Patients with pleural effusion or pneumothorax preoperatively.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo Xinyue Medical Technology Co., LTD

UNKNOWN

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei Liu, MD

Role: CONTACT

liulei12130@pumch.cn

18105369996

Xuehan Gao, MD

Role: CONTACT

gaoxh1299@163.com

18801341299

Facility Contacts

Lei Liu, MD

Role: primary

liulei12130@pumch.cn

18105369996

Xuehan Gao, MD

Role: backup

gaoxh1299@163.com

18801341299

Other Identifiers

TDRWR-1

Identifier Type: -

Identifier Source: org_study_id