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临床试验/NCT05243316
NCT05243316已完成不适用

Risk of 24 Hour-pneumothorax After Chest Tube Removal With and Without Chest Tube Clamping in Patients With Pleural Pathology at the National Institute of Respiratory Diseases

National Institute of Respiratory Diseases, Mexico2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2021年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
2
主要终点
Incidence of pneumothorax after chest tube removal without chest tube clamping

研究概览

简要总结

Through this randomized controlled clinical trial, we aim to identify whether there is a difference in the incidence of 24 hour pneumothorax after chest tube removal, in two blindly randomized groups of patients: The first group with chest tube clamping 6 hours prior to removal, and the second group there will be no chest tube clamping.

The data will be prospectively collected from patient records from the National Institute of Respiratory Diseases Ismael Cosío Villegas.

详细描述

Patients with an indication of chest tube removal will be randomized to two possible arms: clamping (for 6 hours before removal) or not clamping (immediate removal).

Incidence of 24hour pneumothorax after chest tube removal will be recorded.

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 (Outcomes Assessor)

盲法说明

Randomizing will be masked, as well as data analysis.

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 16 years and more.
  • Patients hospitalized in the National Institute of Respiratory Diseases.
  • Patients who had a chest tube placement during their stay at the hospital, by any cause.

排除标准

  • Patients who refuse to sign the informed consent and who refuse to participate in the study.
  • Patients who die before randomization.
  • Patients who gets chest tube removal before being randomized.

结局指标

主要结局

Incidence of pneumothorax after chest tube removal without chest tube clamping

时间窗: After 24 hours of procedure

Cases of pneumothorax after chest tube removal despite clamping

Incidence of pneumothorax after chest tube removal with chest tube clamping

时间窗: After 24 hours of procedure

Cases of pneumothorax after chest tube removal despite clamping

次要结局

  • Hospital days of stay(Through study completion, an average of 1 month)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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