Improvement and Application of New Closed Drainage Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2021-09-30

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.

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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.

Conditions

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Hydrothorax Pneumothorax

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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New Closed Drainage Device

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.

Group Type EXPERIMENTAL

New Closed Drainage Device

Intervention Type DEVICE

For the first group, a new closed drainage device was adopted.

Traditional Closed Drainage Device

We use traditional closed drainage devices for patients with hemothorax and pneumothorax.

Group Type EXPERIMENTAL

Traditional closed drainage device

Intervention Type DEVICE

For group 2, conventional closed drainage device was used.

Interventions

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New Closed Drainage Device

For the first group, a new closed drainage device was adopted.

Intervention Type DEVICE

Traditional closed drainage device

For group 2, conventional closed drainage device was used.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No