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临床试验/NCT05601076
NCT05601076已完成不适用

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

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2019年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
139
试验地点
1
主要终点
the pain numerical rating scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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

Experimental

干预措施: fixed with the triple-buffer system (Procedure)

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

Active Comparator

干预措施: fixed using the conventional lifting platform method (Procedure)

结局指标

主要结局

the pain numerical rating scale

时间窗: 2 hours

no pain: 0 points, mild pain: 1-3 points, moderate pain: 4-7 points and severe pain: 8-10 points

The adverse reactions

时间窗: 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.

The extubation standard

时间窗: 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 Kolcaba comfort scalea(four-point scale)

时间窗: 2 hours

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

次要结局

未报告次要终点

研究者

发起方
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Caifang Yang

director

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

研究点 (1)

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