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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03791437
Other study ID # CGMH-IRB-201701495A3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2023

Study information

Verified date March 2022
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 253
Est. completion date December 31, 2023
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Digital chest drainage system
patients who received Digital chest drainage system
Not use Digital chest drainage system
patients who not received Digital chest drainage system( traditional drainage system)

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other Patient Daily Activity Using Wearable Device for monitor patient's sleep quality and activity Until patient discharge from our hospital
Primary 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 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
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