Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06410716 |
| Other study ID # |
TDRWR-1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2024 |
| Est. completion date |
April 30, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Peking Union Medical College Hospital |
| Contact |
Lei Liu, MD |
| Phone |
18105369996 |
| Email |
liulei12130[@]pumch.cn |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
