Improvement and Application of New Closed Drainage Device (IAAONCDD)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pneumothorax; Hydrothorax
• Intervention / Treatment: Device: New Closed Drainage Device; Device: Traditional closed drainage device

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenli Wang, Master's degree; Phone Number: +86021661110 13761295864; Email: Anderson840913@163.com
• Study Contact Backup: Name: Yongxin zhou; Phone Number: 8602166111070 13681666828; Email: zhou6302@tongji.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: New Closed Drainage Device; For the first group, a new closed drainage device was adopted.
EXPERIMENTAL: Traditional Closed Drainage Device; We use traditional closed drainage devices for patients with hemothorax and pneumothorax.	Device: Traditional closed drainage device; For group 2, conventional closed drainage device was used.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time of thoracentesis	Operation time of thoracentesis	up to 24 hours
Percentage of lung recruitment on day 1 and 3	Percentage of lung recruitment	up to 24 weeks
Operational-related complications	Incidence of loss of thoracic wall nerves, intercostal vessels and thoracic and abdominal organs	up to 24 weeks
Incidence of related accidents after catheterization	Incidence rate of peri-drainage tube exudation, drainage tube falling off, drainage tube obstruction and subcutaneous emphysema	up to 24 weeks
The size of the wound	The size of the wound	up to 24 weeks
infection of the wound	infection of the wound	up to 24 weeks

Collaborators and Investigators

• Sponsor: Yongxin Zhou

Publications and helpful links

General Publications

• Wang WP, Ni YF, Wei YN, Li XF, Cheng QS, Lu Q. Bronchiolitis obliterans complicating a pneumothorax after Stevens-Johnson syndrome induced by lamotrigine. J Formos Med Assoc. 2015 Mar;114(3):285-9. doi: 10.1016/j.jfma.2012.02.026. Epub 2012 Jun 6.
• Khan BA, Reddy PM, Khan AM. Spontaneous pneumothorax in the immediate post-operative hour in a primigravida following emergency caesarean section under spinal anaesthesia. Indian J Anaesth. 2015 Feb;59(2):126-9. doi: 10.4103/0019-5049.151380. No abstract available.

Helpful Links

• pubmed
• pubmed

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2020
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): September 30, 2021

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: October 26, 2019
• First Posted (ACTUAL): October 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 16, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax; Hydrothorax
• Other Study ID Numbers: 2018-LCYJ-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No