Improvement and Application of New Closed Drainage Device

Study Overview
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Brief Summary
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According to the problems of traditional closed thoracic drainage in clinical work, this study aims to further improve and improve the new closed thoracic drainage system by changing the material of drainage tube, increasing the regulating valve of external fixator and increasing the gas flow monitoring kit for special patients, so as to expand its clinical application scope and formulate its operation. Standardize. At the same time, through a randomized controlled study, the simplicity, effectiveness and safety of the new minimally invasive thoracic closed drainage system developed by the research group were deeply studied.

Detailed Description
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The traditional closed thoracic drainage method has complex operation and high technical requirements. It has obvious pain during and after operation. Operational complications such as tissue organs, intercostal vessels and nerve injury may occur during the operation. Accidents may also occur after catheterization, including leakage around thoracic drainage tube, thoracic drainage tube prolapse, subcutaneous emphysema and accumulation. Liquid; To solve these problems, we have invented minimally invasive thoracic closed drainage system through a number of patent designs, including: thoracic closed drainage tube implantation expansion forceps, double-chamber thoracic drainage device with side balloon, guide wire, puncture needle, various types of dilators, chest tube fixation devices, etc. The system has the characteristics of minimally invasive puncture and implantation of drainage tube, safe, fast operation, no need of suture and fixation, good position of drainage tube after implantation, less pain for patients, and closing incision in the medial part of patients, avoiding leakage and subcutaneous emphysema and hydrops.

Official Title
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Improvement and Clinical Application of a New Minimally Invasive Closed Thoracic Drainage System

Conditions
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Hydrothorax, Pneumothorax

Intervention / Treatment
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* Device: New Closed Drainage Device
* Device: Traditional closed drainage device


Participation Criteria
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Eligibility Criteria
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The selection criteria were as follows: age 18-70 years, gender is not limited; subjects clearly understand the purpose of the study, are willing and able to comply with the requirements to complete the study and sign the informed consent; 18 Kg/m2 < BMI < 25 Kg/m2; patients who need thoracic closed drainage for exhaust and drainage because of pneumothorax volume > 30%; subjects did not have serious chest wall deformities. Exclusion criteria: Patients at high risk of bleeding, including patients with congenital hemophilia, thrombocytopenia (PLT < 50 *109/L), platelet dysfunction (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet dysfunction); Cardiopulmonary function is poor, which is not suitable for the participants. Patients with other infectious diseases (inflammation, tuberculosis) or empyema in the thoracic cavity; Infection of skin around puncture and drainage; Participated in other clinical trials within 30 days; Other reasons why the researchers think it is inappropriate to participate in the experiment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Closed Drainage Device<br>We further improve the new closed thoracic drainage system by changing the material of drainage tube, adding external fixator control valve and increasing the gas flow monitoring kit for special patients, and apply it in clinical practice. | Device: New Closed Drainage Device<br>* For the first group, a new closed drainage device was adopted.<br>|
| Experimental: Traditional Closed Drainage Device<br>We use traditional closed drainage devices for patients with hemothorax and pneumothorax. | Device: Traditional closed drainage device<br>* For group 2, conventional closed drainage device was used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total drainage time | Efficiency of treatment | up to 24 weeks | 
| Pulmonary reexpansion ratio | Pulmonary reexpansion ratio | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score during and after operation | 0 points means no pain; 1 points - 3 points means mild pain that patients can tolerate; 4 points - 6 points means pain affect sleep, but patients can tolerate;7 points - 10 points: means patients have gradually strong pain, which have affected appetite and sleep. | up to 24 weeks |