Optimization of Chest Tube Drainage Management

NCT ID: NCT03791437

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experiment groups

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

Group Type: EXPERIMENTAL

Digital chest drainage system

Intervention Type: DEVICE

patients who received Digital chest drainage system

Control groups

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

Group Type: ACTIVE_COMPARATOR

Not use Digital chest drainage system

Intervention Type: DEVICE

patients who not received Digital chest drainage system( traditional drainage system)

Interventions

Digital chest drainage system

patients who received Digital chest drainage system

Intervention Type: DEVICE

Not use Digital chest drainage system

patients who not received Digital chest drainage system( traditional drainage system)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-Feng Wu, MD

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

CGMH-IRB-201701495A3

Identifier Type: -

Identifier Source: org_study_id