NCT04143360

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

September 29, 2019

Last Update Submit

February 16, 2020

Conditions

HydrothoraxPneumothorax

Outcome Measures

Primary Outcomes (2)

  • Total drainage time

    Efficiency of treatment

    up to 24 weeks

  • Pulmonary reexpansion ratio

    Pulmonary reexpansion ratio

    up to 24 weeks

Secondary Outcomes (1)

  • VAS pain score during and after operation

    up to 24 weeks

Other Outcomes (6)

  • Operation time of thoracentesis

    up to 24 hours

  • Percentage of lung recruitment on day 1 and 3

    up to 24 weeks

  • Operational-related complications

    up to 24 weeks

  • +3 more other outcomes

Study Arms (2)

New Closed Drainage Device

EXPERIMENTAL

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

Traditional Closed Drainage Device

EXPERIMENTAL

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

Device: Traditional closed drainage device

Interventions

New Closed Drainage DeviceDEVICE

For the first group, a new closed drainage device was adopted.

New Closed Drainage Device
Traditional closed drainage deviceDEVICE

For group 2, conventional closed drainage device was used.

Traditional Closed Drainage Device

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25777978RESULT

  • 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.

    PMID: 25788749RESULT

Related Links

MeSH Terms

Conditions

HydrothoraxPneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Central Study Contacts

Wenli Wang, Master's degree

CONTACT

13761295864Anderson840913@163.com

Yongxin zhou

CONTACT

13681666828zhou6302@tongji.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 29, 2019

First Posted

October 29, 2019

Study Start

April 1, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share