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

A Randomized Controlled Study Comparing Valve-regulated Pleural Drainage System to Traditional Closed Chest Tube Drainage

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06410716
Enrollment
100
Registered
2024-05-13
Start date
2024-04-20
Completion date
2025-04-30
Last updated
2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

lung cancer, thoracic drainage system

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.

Interventions

DEVICEValve-regulated pleural drainage system

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

Sponsors

Ningbo Xinyue Medical Technology Co., LTD
CollaboratorUNKNOWN
Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention model description

Random number table

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative drainage durationFrom surgery to chest tube removalPostoperative drainage duration

Secondary

MeasureTime frameDescription
Numerical Rating Scale (NRS) coresFrom surgery to chest tube removalThe Numeric Rating Scale (NRS) will be used in assessing pain intensity of patients. The pain intensity of patients is measured on a scale from 0 to 10, with 0 representing no pain and 10 representing the most intense pain.
Postoperative oxyhemoglobin saturation (SpO2)From surgery to chest tube removalPostoperative drainage duration

Countries

China

Contacts

Primary ContactLei Liu, MD
liulei12130@pumch.cn18105369996
Backup ContactXuehan Gao, MD
gaoxh1299@163.com18801341299

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026