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临床试验/NCT04438317
NCT04438317已完成不适用

Thoracic Drains in Intensive Care Units. Comparison of Seldinger and Surgical Methods: A Prospective Randomized Multicenter Study

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 227 人开始时间: 2020年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
227
试验地点
1
主要终点
Composite criteria of major and minor complications related to chest drainage

研究概览

简要总结

This prospective randomized multicenter study is intended to investigate tolerance and effectiveness of thoracic drainage conducted by Seldinger technique with small drains, or by a surgical-like technique with large armed drains, in intensive care units patients.

详细描述

Drainage of pleural effusion and pneumothorax is a common feature in Resuscitation, Intensive Care Units (ICU) and Continuing Care Units (CCU). Although they are associated with a low incidence of complications (ranging from 0 to 8%), some of these can become fatal if they are associated with a visceral puncture (liver, spleen, lung parenchyma or heart by instance). It has been reported in the literature that complications were greater in case of drainage with large diameter drains set up by so-called "surgical-like" technique.

The choice of the type of chest tube is usually guided by the indication of drainage or the habits and / or experience of the practitioner. In the case of liquid pleural effusions, it may be preferable to use small diameter drains, whereas in the case of suspicious thick effusions such as empyema or blood, it may be preferable to use drainage drains of a larger diameter. However, results of retrospective analyzes seem to suggest the versatile and effective use of small-bore chest tubes in any of these indications without increasing complications' rates such as clogging.

However, no prospective randomized controlled trial (RCT) has studied this issue to date. Therefore, the investigators propose to perform a multicenter RCT in ICU and CCU patients requiring pleural drainage for any indication or underlying disease.

This prospective RCT is intended to investigate tolerance and effectiveness of thoracic drainage conducted by Seldinger technique with small drains, or by a surgical-like technique with large armed drains. Furthermore, they want to estimate the respective costs, identify the difficulties related to both strategies, recognize associated practices (ultrasound-guidance, implantation site, operator's competence), and finally point out the secondary determinants of tolerance and effectiveness.

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

Since the study is based on two different techniques, the masking of participants, care providers and local investigator is impossible.

入排标准

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

入选标准

  • Of-age patient (>18years)
  • Patient admitted in ICU or CCU
  • Patient requiring a pleural drainage, semi-urgent or planned
  • Patient with a social security insurance

排除标准

  • Patient under guardianship
  • Severe or uncompensated bleeding disorders
  • Thoracic trauma at the acute phase (<6 hours)
  • Compressive pneumothorax requiring immediate and urgent needle exsufflation
  • No thoracic drainage (whatever the technique used) performed previously during the same stay in ICU or CCU.

结局指标

主要结局

Composite criteria of major and minor complications related to chest drainage

时间窗: ICU discharge up to 6 months

1. a composite criterion for major complications: organic lesions (spleen, liver, lung, artery, vessel ..., calculated frequency 0.2-1.4%) and post-drainage empyema or infection at the site level insertion rate (calculated frequency 0.2-1.4%) (non-inferiority hypothesis) and 2. a composite criterion on the other complications (malposition of the drain (calculated frequency of 0.6-6.5%), clogging of the drain (calculated frequency of 8.1-5.2%) or drain drop (calculated frequency 1-21%) (hypothesis of superiority).

次要结局

  • Doctor performing drainage(Immediately after the pleural drainage procedure)
  • Procedural criteria(Immediately after the pleural drainage procedure)
  • Persistent residual pain: numerical pain scale(ICU discharge up to 6 months)
  • Evaluation of Pain(Before, during, immediately after the procedure)
  • Sedation and analgesia doses(Before, during, immediately after the procedure, every day until the removal of the chest tube, immediately after ICU discharge, Day 28 and Day 90)
  • Evaluation of pain type(Before, during, immediately after the procedure, every day until the removal of the chest tube, immediately after ICU discharge, Day 28 and Day 90)
  • Ultrasound use(Immediately after the pleural drainage procedure)
  • General characteristics(Immediately after the pleural drainage procedure)
  • Complications' rates(During the pleural drainage procedure and ICU discharge up to 6 months)
  • Patients outcomes(Day 90)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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