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Trial Title:
Comparing Valve-regulated Pleural Drainage to Traditional Closed Chest Tube Drainage
NCT ID:
NCT06410716
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
lung cancer
thoracic drainage system
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Random number table
Primary purpose:
Device Feasibility
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Valve-regulated pleural drainage system
Description:
Patients using valve-regulated pleural drainage system (Ningbo Xinyue Medical Technology
Co., Ltd., model AFG31-1) postoperatively.
Arm group label:
Valve-regulated pleural drainage system
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Liu, MD
Phone:
18105369996
Email:
liulei12130@pumch.cn
Contact backup:
Last name:
Xuehan Gao, MD
Phone:
18801341299
Email:
gaoxh1299@163.com
Investigator:
Last name:
Lei Liu, MD
Email:
Principal Investigator
Investigator:
Last name:
Xuehan Gao, MD
Email:
Sub-Investigator
Start date:
April 20, 2024
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Ningbo Xinyue Medical Technology Co., LTD
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06410716
