Small-diameter Closed Thoracic Drainage Tube Fixation Method

NCT ID: NCT05601076

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-02
• Study Completion Date: 2022-07-30

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The drainage tube in the experimental group was fixed with the triple-buffer system

Group Type: EXPERIMENTAL

fixed with the triple-buffer system

Intervention Type: PROCEDURE

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.

that in the control group was fixed using the conventional lifting platform method

Group Type: ACTIVE_COMPARATOR

fixed using the conventional lifting platform method

Intervention Type: PROCEDURE

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

Interventions

fixed with the triple-buffer system

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.

Intervention Type: PROCEDURE

fixed using the conventional lifting platform method

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Caifang Yang

director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caifang Yang, Dr.

Role: STUDY_DIRECTOR

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Locations

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Taizhou, Zhejiang, China

Countries

China

Other Identifiers

Taizhouhospital002

Identifier Type: -

Identifier Source: org_study_id