Clinical Trials Directory

Trials / Completed

CompletedNCT06683976

Evaluating Improvised Chest Drainage Techniques in Conflict Zones

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

Status
Completed
Phase
Study type
Observational
Enrollment
180 (actual)
Sponsor
Sudan Medical Specialization Board · Other Government
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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: Data on each patient's clinical course and intervention will be recorded, focusing on primary outcomes like successful lung re-expansion and infection, and secondary outcomes, including procedural feasibility and cost. Comparative statistical analysis will assess outcome differences between groups. Ethical Compliance: Institutional review board (IRB) approval will be obtained, with all patient data anonymized and securely stored. Informed consent will be obtained from all participants or their guardians. Impact Statement: By assessing improvised methods in trauma care within a resource-limited context, this study could inform adaptable practices for similar environments worldwide, potentially influencing trauma care protocols and patient outcomes in challenging settings.

Conditions

Timeline

Start date
2023-06-01
Primary completion
2023-12-01
Completion
2023-12-10
First posted
2024-11-12
Last updated
2025-01-06

Locations

1 site across 1 country: Sudan

Source: ClinicalTrials.gov record NCT06683976. Inclusion in this directory is not an endorsement.