Evaluating Improvised Chest Drainage Techniques in Conflict Zones

Completed

• Conditions: Pneumothorax; Hemothorax; Thoracic Trauma; Flail Chest; Hemopneumothorax; Traumatic

• Registration Number: NCT06683976
• Lead Sponsor: Sudan Medical Specialization Board

Brief 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.

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-10
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-09
• Study First Posted: 2024-11-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Successful Lung Re-expansion	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.

Secondary Outcome Measures

Name	Time	Method
Rate of Drainage-Related Infections	Up to 30 days post-procedure	Number of participants with infections directly associated with the chest drainage procedure, including pleural or wound infections, documented by clinical signs and laboratory findings.
Median Length of Hospital Stay	From admission to discharge (typically within 30 days)	Median number of days from admission to discharge for each participant, allowing for the assessment of recovery duration associated with each drainage method.

Trial Locations

Locations (1)

Wad Madani teaching Hospital; 🇸🇩 Wad Madani, Gezira, Sudan