Improvement and Application of New Closed Drainage Device

Not Applicable

• Conditions: Hydrothorax; Pneumothorax
• Interventions: Device: New Closed Drainage Device; Device: Traditional closed drainage device

• Registration Number: NCT04143360
• Lead Sponsor: Yongxin Zhou

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-09-29
• Study First Submitted QC: 2019-10-26
• Study First Posted: 2019-10-29
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-16
• Last Update Posted: 2020-02-18
• Study Start: 2020-04
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New Closed Drainage Device	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.
Traditional Closed Drainage Device	Traditional closed drainage device	We use traditional closed drainage devices for patients with hemothorax and pneumothorax.

Primary Outcome Measures

Name	Time	Method
Total drainage time	up to 24 weeks	Efficiency of treatment
Pulmonary reexpansion ratio	up to 24 weeks	Pulmonary reexpansion ratio

Secondary Outcome Measures

Name	Time	Method
VAS pain score during and after operation	up to 24 weeks	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.