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
About this trial
This is an interventional treatment trial for Hydrothorax
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.
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
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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