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Improvement and Application of New Closed Drainage Device (IAAONCDD)

Primary Purpose

Hydrothorax, Pneumothorax

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
New Closed Drainage Device
Traditional closed drainage device
Sponsored by
Yongxin Zhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydrothorax

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    New Closed Drainage Device

    Traditional Closed Drainage Device

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Total drainage time
    Efficiency of treatment
    Pulmonary reexpansion ratio
    Pulmonary reexpansion ratio

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 29, 2019
    Last Updated
    February 16, 2020
    Sponsor
    Yongxin Zhou
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04143360
    Brief Title
    Improvement and Application of New Closed Drainage Device
    Acronym
    IAAONCDD
    Official Title
    Improvement and Clinical Application of a New Minimally Invasive Closed Thoracic Drainage System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2020 (Anticipated)
    Primary Completion Date
    September 30, 2021 (Anticipated)
    Study Completion Date
    September 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yongxin Zhou

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hydrothorax, Pneumothorax

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    New Closed Drainage Device
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Traditional Closed Drainage Device
    Arm Type
    Experimental
    Arm Description
    We use traditional closed drainage devices for patients with hemothorax and pneumothorax.
    Intervention Type
    Device
    Intervention Name(s)
    New Closed Drainage Device
    Intervention Description
    For the first group, a new closed drainage device was adopted.
    Intervention Type
    Device
    Intervention Name(s)
    Traditional closed drainage device
    Intervention Description
    For group 2, conventional closed drainage device was used.
    Primary Outcome Measure Information:
    Title
    Total drainage time
    Description
    Efficiency of treatment
    Time Frame
    up to 24 weeks
    Title
    Pulmonary reexpansion ratio
    Description
    Pulmonary reexpansion ratio
    Time Frame
    up to 24 weeks
    Secondary Outcome Measure Information:
    Title
    VAS pain score during and after operation
    Description
    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.
    Time Frame
    up to 24 weeks
    Other Pre-specified Outcome Measures:
    Title
    Operation time of thoracentesis
    Description
    Operation time of thoracentesis
    Time Frame
    up to 24 hours
    Title
    Percentage of lung recruitment on day 1 and 3
    Description
    Percentage of lung recruitment
    Time Frame
    up to 24 weeks
    Title
    Operational-related complications
    Description
    Incidence of loss of thoracic wall nerves, intercostal vessels and thoracic and abdominal organs
    Time Frame
    up to 24 weeks
    Title
    Incidence of related accidents after catheterization
    Description
    Incidence rate of peri-drainage tube exudation, drainage tube falling off, drainage tube obstruction and subcutaneous emphysema
    Time Frame
    up to 24 weeks
    Title
    The size of the wound
    Description
    The size of the wound
    Time Frame
    up to 24 weeks
    Title
    infection of the wound
    Description
    infection of the wound
    Time Frame
    up to 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wenli Wang, Master's degree
    Phone
    13761295864
    Ext
    +86021661110
    Email
    Anderson840913@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yongxin zhou
    Phone
    13681666828
    Ext
    8602166111070
    Email
    zhou6302@tongji.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25777978
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    25788749
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/?term=Bronchiolitis+obliterans+complicating+a+poeumothorax+after+Stevens-+Johson+syndrome+induced+by+lamotrigine.
    Description
    pubmed
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/?term=Spontaneous+pneumothorax+in+the+immediate+post-operative+hour+in+a+primigravida+following+emergency+caesarean+section+under+spinal+anaesthesia.
    Description
    pubmed

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    Improvement and Application of New Closed Drainage Device

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