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Completed

NCT Number: NCT05601076

Small-diameter Closed Thoracic Drainage Tube Fixation Method

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.

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Key information

Conditions

Pulmonary Wedge Resection

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Taizhou, Zhejiang, 317000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fixed with the triple-buffer system

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.

fixed using the conventional lifting platform method

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

Primary outcomes

  1. 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.

  2. 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

  3. the Kolcaba comfort scalea(four-point scale)

    Time frame: 2 hours

    1: strongly disagree, 2: disagree, 3: agree, 4: strongly agree

  4. 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.

Sponsors and collaborators

Lead sponsor

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Other

Registry information

Official study title

Design and Application of Small-diameter Closed Thoracic Drainage Tube Fixation Following Lung Wedge Resection: a Randomised Prospective Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Nov 1, 2022
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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