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Optimization of Chest Tube Drainage Management

Primary Purpose

Lung Diseases, Age >18 Years-old, Patient Who Received Thoracoscope Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Digital chest drainage system
Not use Digital chest drainage system
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Diseases focused on measuring digital chest tube system, shorten hospital stay

Eligibility Criteria

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

Inclusion Criteria:

  • Volunteer to join the study after thoroughly explanations
  • Patient who received thoracoscope surgery for lung lesion

Exclusion Criteria:

  • Not willing to join the study after thoroughly explanations
  • Patients who have not received thoracoscope surgery for lung lesion

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experiment groups

Control groups

Arm Description

Post chest operative use Digital chest drainage system until Patient's discharge day

Post chest operative use traditional drainage system until Patient's discharge day Not use Digital chest drainage system

Outcomes

Primary Outcome Measures

Air leak graph of digital drainage system
Compare Digital chest drainage system with traditional drainage system

Secondary Outcome Measures

Days of hospital stay after surgery
Compare Digital chest drainage system with traditional drainage system

Full Information

First Posted
December 13, 2018
Last Updated
April 6, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03791437
Brief Title
Optimization of Chest Tube Drainage Management
Official Title
Optimization of Chest Tube Drainage Management to Shorten Postoperative Hospital Stay and Increase Satisfaction of Patients After Video-Assisted Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

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
Early recovery after surgery was new developing science in recent years. However , there was few reports in thoracic surgery field . Investigators try to using digital chest drainage management system into the field of postoperative care and to see whether it could help patients to recovery from surgery as soon as possible. According to investigators's clinical data collecting , investigators will establish a new postoperative care guideline for those patients who receive thoracic surgery
Detailed Description
Drainage of the space between the ribs and lungs has been practiced since the time of Hippocrates. Thus far, the function of chest tubes, specifically to drain fluid or air from the pleural space, has virtually remained unchanged for more than 3000 years. The use of chest drainage tubes after thoracic surgery is crucial to evacuate air leakage and/or pleural effusion; however, delayed tube removal may exacerbate pain, delay recovery of lung function and prolong hospitalization. Recently, Thopaz digitally monitored thoracic drainage system (Medela Healthcare, Baar, Switzerland)has been designed to provide objective measurements of air leakage and pleural pressure. With this system, air leakage and pleural pressure can be accurately measured in mL/min and mm H2O, respectively. The rate of air leakage can be seen on a display in real time. Digital surveillance for air leakage is reported to reduce interobserver disagreement in decision making in the management of patients with chest tubes, which might help caregiver a more solid evidence of strategies of postoperative chest drainage care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Age >18 Years-old, Patient Who Received Thoracoscope Surgery
Keywords
digital chest tube system, shorten hospital stay

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
digital chest drainage system
Masking
None (Open Label)
Allocation
Randomized
Enrollment
366 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment groups
Arm Type
Experimental
Arm Description
Post chest operative use Digital chest drainage system until Patient's discharge day
Arm Title
Control groups
Arm Type
Active Comparator
Arm Description
Post chest operative use traditional drainage system until Patient's discharge day Not use Digital chest drainage system
Intervention Type
Device
Intervention Name(s)
Digital chest drainage system
Intervention Description
patients who received Digital chest drainage system
Intervention Type
Device
Intervention Name(s)
Not use Digital chest drainage system
Intervention Description
patients who not received Digital chest drainage system( traditional drainage system)
Primary Outcome Measure Information:
Title
Air leak graph of digital drainage system
Description
Compare Digital chest drainage system with traditional drainage system
Time Frame
Follow patient 's condition in OPD post surgery in two years
Secondary Outcome Measure Information:
Title
Days of hospital stay after surgery
Description
Compare Digital chest drainage system with traditional drainage system
Time Frame
Follow patient 's condition in OPD post surgery in two years
Other Pre-specified Outcome Measures:
Title
Fluid graph of digital drainage system
Description
Compare Digital chest drainage system with traditional drainage system
Time Frame
Follow patient 's condition in OPD post surgery in two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Volunteer to join the study after thoroughly explanations Patient who received thoracoscope surgery for lung lesion Exclusion Criteria: Not willing to join the study after thoroughly explanations Patients who have not received thoracoscope surgery for lung lesion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Feng Wu, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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Optimization of Chest Tube Drainage Management

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