Lung DiseasesNCT03791437
Optimization of Chest Tube Drainage Management
A study testing Digital chest drainage system and Not use Digital chest drainage system in people with Lung Diseases and Age >18 Years-old, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Age >18 Years-old, Patient Who Received Thoracoscope Surgery
- What is being tested?
- Digital chest drainage system and Not use Digital chest drainage system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to join the study after thoroughly explanations
- Patient who received thoracoscope surgery for lung lesion
Who cannot join
- Not willing to join the study after thoroughly explanations
- Patients who have not received thoracoscope surgery for lung lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- Digital chest drainage system, Not use Digital chest drainage system
- Keywords
- digital chest tube system, shorten hospital stay
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital chest drainage systemDevice
patients who received Digital chest drainage system
Not use Digital chest drainage systemDevice
patients who not received Digital chest drainage system( traditional drainage system)
| Study group | Role | What they receive |
|---|---|---|
| Experiment groups | Experimental | Post chest operative use Digital chest drainage system until Patient's discharge day Receives: Device: Digital chest drainage system |
| Control groups | Active comparator | Post chest operative use traditional drainage system until Patient's discharge day Not use Digital chest drainage system Receives: Device: Not use Digital chest drainage system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Air leak graph of digital drainage system
Compare Digital chest drainage system with traditional drainage system
Measured: Follow patient 's condition in OPD post surgery in two years
Secondary outcomes (1)
Days of hospital stay after surgery
Compare Digital chest drainage system with traditional drainage system
Measured: Follow patient 's condition in OPD post surgery in two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- digital chest drainage system
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Feng Wu, MD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791437
- Sponsor's protocol ID
- CGMH-IRB-201701495A3
- Status last verified
- Mar 2022
- First submitted
- 13 Dec 2018
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Chest Tube Drainage Management to Shorten Postoperative Hospital Stay and Increase Satisfaction of Patients After Video-Assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03791437
- Acronym / sponsor ID
- CGMH-IRB-201701495A3
- Keywords
- digital chest tube system, shorten hospital stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- digital chest drainage system
| Arm | Type | Receives |
|---|---|---|
| Experiment groups | Experimental | Device: Digital chest drainage systemPost chest operative use Digital chest drainage system until Patient's discharge day |
| Control groups | Active comparator | Device: Not use Digital chest drainage systemPost chest operative use traditional drainage system until Patient's discharge day Not use Digital chest drainage system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteer to join the study after thoroughly explanations
- Patient who received thoracoscope surgery for lung lesion
Key exclusion criteria (2 listed)
- Not willing to join the study after thoroughly explanations
- Patients who have not received thoracoscope surgery for lung lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital chest drainage systempatients who received Digital chest drainage system | Device | Experiment groups |
| Not use Digital chest drainage systempatients who not received Digital chest drainage system( traditional drainage system) | Device | Control groups |
Primary outcome
Air leak graph of digital drainage system
Time frame: Follow patient 's condition in OPD post surgery in two years
Compare Digital chest drainage system with traditional drainage system
1 secondary outcome
Days of hospital stay after surgery
Time frame: Follow patient 's condition in OPD post surgery in two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-Feng Wu, MD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital chest drainage system and Not use Digital chest drainage system in people with Lung Diseases and Age >18 Years-old, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Air leak graph of digital drainage system (time frame: Follow patient 's condition in OPD post surgery in two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.