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Lung CancerNCT06410716

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

A study testing Valve-regulated pleural drainage system in people with Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Valve-regulated pleural drainage system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
20 Apr 2024to 30 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who accepted thoracoscopic lobectomy and lymph node dissection;
  • Written consent is able to obtained.

Who cannot join

  • Pregnant or lactating women;
  • Patients with significant dysfunction of organs such as the heart, liver, or kidneys;
  • Patients with pleural effusion or pneumothorax preoperatively.

Trial locations and contacts

1 site in 1 country.

Xuehan Gao, MD contact

18801341299

gaoxh1299@163.com

China1 site, 1 recruiting
  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Lei Liu, MD, 18105369996, liulei12130@pumch.cn

    Xuehan Gao, MD, 18801341299, gaoxh1299@163.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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
Being tested
Valve-regulated pleural drainage system
Keywords
lung cancer, thoracic drainage system
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Valve-regulated pleural drainage systemDevice

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

Study groups in NCT06410716
Study groupRoleWhat they receive
Valve-regulated pleural drainage systemExperimentalPatients using valve-regulated pleural drainage system.
Receives: Device: Valve-regulated pleural drainage system
Closed chest tube drainageNo interventionPatients using traditional closed chest tube drainage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative drainage duration

    Postoperative drainage duration

    Measured: From surgery to chest tube removal

Secondary outcomes (2)
  1. Numerical Rating Scale (NRS) cores

    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".

    Measured: From surgery to chest tube removal

  2. Postoperative oxyhemoglobin saturation (SpO2)

    Postoperative drainage duration

    Measured: From surgery to chest tube removal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2024
  2. Study start20 Apr 2024
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Randomised
Intervention model
Parallel groups
Model description
Random number table
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06410716
Sponsor's protocol ID
TDRWR-1
Status last verified
May 2024
First submitted
8 May 2024
Last updated
17 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The research results have not been published.

Questions about this trial

What is this clinical trial studying?

A study testing Valve-regulated pleural drainage system in people with Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lei Liu, MD (18105369996, liulei12130@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative drainage duration (time frame: From surgery to chest tube removal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.

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