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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lei Liu, MD
- Phone Number: 18105369996
- Email: liulei12130@pumch.cn
Study Contact Backup
- Name: Xuehan Gao, MD
- Phone Number: 18801341299
- Email: gaoxh1299@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital
-
Sub-Investigator:
- Xuehan Gao, MD
-
Contact:
- Lei Liu, MD
- Phone Number: 18105369996
- Email: liulei12130@pumch.cn
-
Contact:
- Xuehan Gao, MD
- Phone Number: 18801341299
- Email: gaoxh1299@163.com
-
Principal Investigator:
- Lei Liu, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who accepted thoracoscopic lobectomy and lymph node dissection;
- Written consent is able to obtained.
Exclusion Criteria:
- Pregnant or lactating women;
- Patients with significant dysfunction of organs such as the heart, liver, or kidneys;
- Patients with pleural effusion or pneumothorax preoperatively.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Valve-regulated pleural drainage system
Patients using valve-regulated pleural drainage system.
|
Patients using valve-regulated pleural drainage system (Ningbo Xinyue Medical Technology Co., Ltd., model AFG31-1) postoperatively.
|
|
No Intervention: Closed chest tube drainage
Patients using traditional closed chest tube drainage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative drainage duration
Time Frame: From surgery to chest tube removal
|
Postoperative drainage duration
|
From surgery to chest tube removal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative oxyhemoglobin saturation (SpO2)
Time Frame: From surgery to chest tube removal
|
Postoperative drainage duration
|
From surgery to chest tube removal
|
|
Numerical Rating Scale (NRS) cores
Time Frame: From surgery to chest tube removal
|
The 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".
|
From surgery to chest tube removal
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDRWR-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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