Clinical trial NCT04143360: Improvement and Application of New Closed Drainage Device
Official title: Improvement and Clinical Application of a New Minimally Invasive Closed Thoracic Drainage System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hydrothorax
Pneumothorax
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Total drainage time
timeFrame: up to 24 weeks
measure: Pulmonary reexpansion ratio
timeFrame: up to 24 weeks
Secondary outcomes:
measure: VAS pain score during and after operation
timeFrame: up to 24 weeks
Other outcomes:
measure: Operation time of thoracentesis
timeFrame: up to 24 hours
measure: Percentage of lung recruitment on day 1 and 3
timeFrame: up to 24 weeks
measure: Operational-related complications
timeFrame: up to 24 weeks
measure: Incidence of related accidents after catheterization
timeFrame: up to 24 weeks
measure: The size of the wound
timeFrame: up to 24 weeks
measure: infection of the wound
timeFrame: up to 24 weeks
Locations:
Study officials:
References:
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.
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.