Optimization of Chest Tube Drainage Management

Optimization of Chest Tube Drainage Management to Shorten Postoperative Hospital Stay and Increase Satisfaction of Patients After Video-Assisted Thoracic Surgery

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

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Age >18 Years-old; Patient Who Received Thoracoscope Surgery
• Intervention / Treatment: Device: Digital chest drainage system; Device: Not use Digital chest drainage system

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.

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experiment groups; Post chest operative use Digital chest drainage system until Patient's discharge day	Device: Digital chest drainage system; patients who received Digital chest drainage system
Active Comparator: Control groups; Post chest operative use traditional drainage system until Patient's discharge day Not use Digital chest drainage system	Device: Not use Digital chest drainage system; patients who not received Digital chest drainage system( traditional drainage system)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Air leak graph of digital drainage system	Compare Digital chest drainage system with traditional drainage system	Follow patient 's condition in OPD post surgery in two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of hospital stay after surgery	Compare Digital chest drainage system with traditional drainage system	Follow patient 's condition in OPD post surgery in two years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid graph of digital drainage system	Compare Digital chest drainage system with traditional drainage system	Follow patient 's condition in OPD post surgery in two years
Patient Daily Activity	Using Wearable Device for monitor patient's sleep quality and activity	Until patient discharge from our hospital

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: Ching-Feng Wu, MD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 28, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: digital chest tube system, shorten hospital stay
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: CGMH-IRB-201701495A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No