Pulmonary Wedge ResectionNCT05601076
Small-diameter Closed Thoracic Drainage Tube Fixation Method
A study testing fixed with the triple-buffer system and fixed using the conventional lifting platform method in people with Pulmonary Wedge Resection, run by Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University at 1 site in China.
Trial summary
Objective: To explore the design feasibility and application effect of triple-buffer-system-fixed small-diameter (18 F) thoracic closed drainage tubes following lung wedge resection. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Wedge Resection
- What is being tested?
- fixed with the triple-buffer system and fixed using the conventional lifting platform method
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2019to 30 Jul 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Single-port thoracoscopic wedge resection of the lung was performed for the first time
- No air leak in the lung tissue was detected
- The patient could communicate and cooperate normally.
- No local skin allergy or scar could be observed.
Who cannot join
- Patients with wide adhesion of the whole thoracic mucosa.
- Patients with postoperative or intraoperative bleeding.
- Patients with severe postoperative hypoproteinaemia or chylothorax with massive pleural effusion.
- Patients diagnosed with emphysema.
Trial locations and contacts
1 site in 1 country.
China1 site
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Taizhou, Zhejiang, 317000
About this study
Official title: Design and Application of Small-diameter Closed Thoracic Drainage Tube Fixation Following Lung Wedge Resection: a Randomised Prospective Study
Objective: To explore the design feasibility and application effect of triple-buffer-system-fixed small-diameter (18 F) thoracic closed drainage tubes following lung wedge resection. Methods: A total of 136 patients with indwelling thoracic drainage tubes following pulmonary wedge resection were recruited, with 70 patients allocated to the control group and 66 to the experimental group. The drainage tube in the experimental group was fixed with the triple-buffer system, while that in the control group was fixed using the conventional lifting platform method. The incidence of unplanned extubation, the indwelling time of the drainage tube and the time and material costs, as well as information regarding any subcutaneous emphysema and skin tension blisters, were recorded following the operation. The pain and degree of comfort were assessed using a chi-square test and a rank sum t-test to compare the differences between the two groups.
- Conditions
- Pulmonary Wedge Resection
- Being tested
- fixed with the triple-buffer system, fixed using the conventional lifting platform method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixed with the triple-buffer systemProcedure or surgery
The steps were as follows: i) elastic cotton tape (3M 2733-25 Japan Ltd., Tokyo, Japan) was used at the proximal 15 cm from the incision, with 5 × 2.5 cm pieces glued to the skin and fixed with the drainage tube using surgical knots; ii) the distal end of the ligation was fixed using the same method, while the ligation position was higher than the first; iii) the ligature point was fixed next to the elastic soft cotton tape (5 × 5 cm), using the high-platform method to fix the drainage tube, with the drainage tube curved; and iv) the drainage tube between the two fixed points was inserted with a specific radian.
fixed using the conventional lifting platform methodProcedure or surgery
In terms of the control group, two lines of flexible cotton tape (3M 2733-25 Japan Ltd., Tokyo, Japan) measuring 10 × 2.5 cm were used, and the drainage tube was fixed parallel to the long axis and glued to the middle-position 360° winding tube once the drainage tube was 0.5 cm higher than the surrounding skin. Next, the drainage tube was fixed at both ends to the patient's skin using adhesive tape. Then, the tube and the adhesive plaster were overlapped vertically and horizontally, the tube was inserted, the adhesive plaster was added, and then the chest tube was fixed on the adhesive plaster by knotting the interspersed cotton rope, which was equal to indirectly fixing the tube on the patient's skin
| Study group | Role | What they receive |
|---|---|---|
| The drainage tube in the experimental group was fixed with the triple-buffer system | Experimental | Not described Receives: Procedure: fixed with the triple-buffer system |
| that in the control group was fixed using the conventional lifting platform method | Active comparator | Not described Receives: Procedure: fixed using the conventional lifting platform method |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extubation standard
The extubation standard is patients with good lung re-expansion after clamping for 24 h and no obvious air leakage after reopening the chest tube, and a drainage volume of <250 mL within 24 h, which can be removed.
Measured: 2 hours
the pain numerical rating scale
no pain: 0 points, mild pain: 1-3 points, moderate pain: 4-7 points and severe pain: 8-10 points
Measured: 2 hours
the Kolcaba comfort scalea(four-point scale)
1: strongly disagree, 2: disagree, 3: agree, 4: strongly agree
Measured: 2 hours
The adverse reactions
The chest skin was bulged, and the gas could be felt in the subcutaneous tissue through hand pressing, and there was a feeling of twisting or snow grip.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start2 Feb 2019
- Primary completion30 Aug 2021
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Wedge ResectionStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caifang Yang, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
- Investigators
- Caifang Yang, Dr., Study director, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601076
- Sponsor's protocol ID
- Taizhouhospital002
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Application of Small-diameter Closed Thoracic Drainage Tube Fixation Following Lung Wedge Resection: a Randomised Prospective Study
- ClinicalTrials.gov ID
- NCT05601076
- Acronym / sponsor ID
- Taizhouhospital002
- Conditions
- Pulmonary Wedge Resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 1 Nov 2022 (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.
Objective: To explore the design feasibility and application effect of triple-buffer-system-fixed small-diameter (18 F) thoracic closed drainage tubes following lung wedge resection. Methods: A total of 136 patients with indwelling thoracic drainage tubes following pulmonary wedge resection were recruited, with 70 patients allocated to the control group and 66 to the experimental group. The drainage tube in the experimental group was fixed with the triple-buffer system, while that in the control group was fixed using the conventional lifting platform method. The incidence of unplanned extubation, the indwelling time of the drainage tube and the time and material costs, as well as information regarding any subcutaneous emphysema and skin tension blisters, were recorded following the operation. The pain and degree of comfort were assessed using a chi-square test and a rank sum t-test to compare the differences between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The drainage tube in the experimental group was fixed with the triple-buffer system | Experimental | Procedure: fixed with the triple-buffer system |
| that in the control group was fixed using the conventional lifting platform method | Active comparator | Procedure: fixed using the conventional lifting platform method |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Single-port thoracoscopic wedge resection of the lung was performed for the first time
- No air leak in the lung tissue was detected
- The patient could communicate and cooperate normally.
- No local skin allergy or scar could be observed.
Key exclusion criteria (4 listed)
- Patients with wide adhesion of the whole thoracic mucosa.
- Patients with postoperative or intraoperative bleeding.
- Patients with severe postoperative hypoproteinaemia or chylothorax with massive pleural effusion.
- Patients diagnosed with emphysema.
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 |
|---|---|---|
| fixed with the triple-buffer systemThe steps were as follows: i) elastic cotton tape (3M 2733-25 Japan Ltd., Tokyo, Japan) was used at the proximal 15 cm from the incision, with 5 × 2.5 cm pieces glued to the skin and fixed with the drainage tube using surgical knots; ii) the distal end of the ligation was fixed using the same method, while the ligation position was higher than the first; iii) the ligature point was fixed next to the elastic soft cotton tape (5 × 5 cm), using the high-platform method to fix the drainage tube, with the drainage tube curved; and iv) the drainage tube between the two fixed points was inserted with a specific radian. | Procedure or surgery | The drainage tube in the experimental group was fixed with the triple-buffer system |
| fixed using the conventional lifting platform methodIn terms of the control group, two lines of flexible cotton tape (3M 2733-25 Japan Ltd., Tokyo, Japan) measuring 10 × 2.5 cm were used, and the drainage tube was fixed parallel to the long axis and glued to the middle-position 360° winding tube once the drainage tube was 0.5 cm higher than the surrounding skin. Next, the drainage tube was fixed at both ends to the patient's skin using adhesive tape. Then, the tube and the adhesive plaster were overlapped vertically and horizontally, the tube was inserted, the adhesive plaster was added, and then the chest tube was fixed on the adhesive plaster by knotting the interspersed cotton rope, which was equal to indirectly fixing the tube on the patient's skin | Procedure or surgery | that in the control group was fixed using the conventional lifting platform method |
Primary outcome
The extubation standard
Time frame: 2 hours
The extubation standard is patients with good lung re-expansion after clamping for 24 h and no obvious air leakage after reopening the chest tube, and a drainage volume of <250 mL within 24 h, which can be removed.
the pain numerical rating scale
Time frame: 2 hours
no pain: 0 points, mild pain: 1-3 points, moderate pain: 4-7 points and severe pain: 8-10 points
the Kolcaba comfort scalea(four-point scale)
Time frame: 2 hours
1: strongly disagree, 2: disagree, 3: agree, 4: strongly agree
The adverse reactions
Time frame: 2 hours
The chest skin was bulged, and the gas could be felt in the subcutaneous tissue through hand pressing, and there was a feeling of twisting or snow grip.
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 1 Nov 2022.
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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.
Caifang Yang, Dr. study director
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fixed with the triple-buffer system and fixed using the conventional lifting platform method in people with Pulmonary Wedge Resection, run by Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University at 1 site in China.
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 4 inclusion and 4 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 1 Nov 2022. 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 China. 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?
The extubation standard (time frame: 2 hours). The study lists 4 primary outcomes in all. 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 1 Nov 2022; AzTrials last refreshed its copy on 30 Oct 2026.