Clinical trial NCT06683976: Evaluating Improvised Chest Drainage Techniques in Conflict Zones
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumothorax
Hemothorax
Thoracic Trauma
Flail Chest
Hemopneumothorax; Traumatic
Keywords: Underwater Seal System Alternatives
Chest Trauma
Improvised Chest Drainage
Nasogastric Tube Chest Drain
Low-Resource Trauma Care
Conflict Zone Healthcare
Pneumothorax Management
Hemothorax Treatment
Alternative Chest Tube Methods
Emergency Thoracic Intervention
Lead sponsor: Sudan Medical Specialization Board
Sponsor class: OTHER_GOV
First posted: 2024-11-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include adult patients (18 years and75 years) presenting with chest trauma at Wad Madani Teaching Hospital, a low-resource and conflict-affected setting. Patients are eligible if they require chest drainage for conditions such as pneumothorax or hemothorax and are stable enough to undergo the procedure. Due to limited resources, chest drainage methods include both standard and improvised techniques. The study population represents individuals receiving trauma care in a low-resource setting, providing insights into the effectiveness and safety of adapted drainage techniques in resource-constrained environments

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients With Successful Lung Re-expansion
timeFrame: Within 72 hours post-drainage
Secondary outcomes:
measure: Rate of Drainage-Related Infections
timeFrame: Up to 30 days post-procedure
measure: Median Length of Hospital Stay
timeFrame: From admission to discharge (typically within 30 days)
Other outcomes:
measure: Patient Satisfaction Score at Discharge
timeFrame: At discharge (up to 30 days post-procedure)
Locations:
city: Wad Madani
country: Sudan
facility: Wad Madani teaching Hospital
state: Gezira
Study officials:
affiliation: University of Gezira, Faculty of medicine
name: Hassan Ali Musa, Consultant
role: STUDY_CHAIR
References: