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临床试验/NCT06683976
NCT06683976已完成不适用

Safety and Efficacy of Improvised Chest Tube Drainage in the Absence of Conventional Systems: a Prospective Single-Center Study in Emergency and Conflict Zones in Sudan

Sudan Medical Specialization Board1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年6月1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
180
试验地点
1
主要终点
Percentage of Patients With Successful Lung Re-expansion

研究概览

简要总结

This study examines the use of improvised chest drainage systems in managing chest trauma at Wad Madani Teaching Hospital, a low-resource and conflict-affected setting. Due to a shortage of standard chest tubes and underwater seal systems, healthcare providers have adapted by using nasogastric (NG) tubes as chest drains and IV drip sets as makeshift underwater seals.

The study aims to evaluate the safety, effectiveness, and feasibility of these improvised methods compared to traditional chest drainage techniques. Primary outcomes will include lung re-expansion success, infection rates, and hospital stay length. By assessing patient outcomes, this study seeks to determine if these adapted techniques can provide a viable alternative for trauma care in resource-limited settings, potentially guiding practices in similar environments globally.

详细描述

This study explores the application of improvised chest drainage systems at Wad Manani Teaching Hospital for managing chest trauma in a low-resource, conflict-affected setting. Due to limited availability of standard medical supplies, an alternative approach has been adopted using nasogastric (NG) tubes as chest drains paired with intravenous (IV) drip sets, modified to act as underwater seals.

The primary aim is to assess the safety and effectiveness of these improvised systems in comparison to conventional chest tube drainage. By focusing on outcomes such as lung re-expansion success, infection rates, and recovery time, this study seeks to establish the clinical viability of improvised drainage systems in emergencies. Secondary evaluations include cost-effectiveness and the role of targeted staff training in improving procedural outcomes.

Study Approach:

This is a 6-months prospective observational study where patients with chest injuries are assigned to either a standard treatment group or an improvised treatment group. The improvised system involves inserting an NG tube as a chest drain connected to a modified IV drip set for underwater sealing. Standard sterile protocols are followed to reduce infection risk.

Data Collection & Analysis:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years and older
  • Patients presenting with chest trauma requiring chest drainage (e.g., pneumothorax, hemothorax)
  • Willingness to provide informed consent to participate in the study -Stable enough to undergo chest X-ray or clinical assessment for lung re- expansion

排除标准

  • Patients with pre-existing severe lung disease or significant comorbidities affecting chest drainage outcomes (e.g., advanced COPD, heart failure)
  • Patients with prior chest surgery that may interfere with drainage outcomes
  • Individuals with contraindications to chest tube insertion or NG tube placement
  • Patients unwilling or unable to provide informed consent

结局指标

主要结局

Percentage of Patients With Successful Lung Re-expansion

时间窗: Within 72 hours post-drainage

The percentage of patients in each group (conventional vs. improvised chest drainage) who achieve full lung re-expansion as confirmed by chest X-ray.

次要结局

  • Rate of Drainage-Related Infections(Up to 30 days post-procedure)
  • Median Length of Hospital Stay(From admission to discharge (typically within 30 days))

研究者

发起方
Sudan Medical Specialization Board
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Alsadig Suliman

Principal Investigator

Sudan Medical Specialization Board

研究点 (1)

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