Evaluating Improvised Chest Drainage Techniques in Conflict Zones

NCT ID: NCT06683976

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-12-10

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.

Conditions

Pneumothorax; Hemothorax; Thoracic Trauma; Flail Chest; Hemopneumothorax; Traumatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard Treatment Group Label: Conventional Chest Drainage

This group includes patients with chest trauma who receive standard chest drainage using commercial chest tubes and underwater seal systems. This intervention follows established guidelines and protocols for chest drainage in trauma care. Patients in this group serve as the control group for comparing outcomes with those receiving improvised drainage systems.

No interventions assigned to this group

Improvised Treatment Group Label: Improvised NG Tube Drainage

This group includes patients with chest trauma who receive chest drainage using improvised methods, specifically nasogastric (NG) tubes as chest drains and intravenous (IV) drip sets adapted to function as underwater seals. This alternative intervention is used due to resource constraints and aims to evaluate the safety and effectiveness of improvised methods in a low-resource, conflict-affected setting

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sudan Medical Specialization Board

OTHER_GOV

Sponsor Role: lead

Responsible Party

Alsadig Suliman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hassan Ali Musa, Consultant

Role: STUDY_CHAIR

University of Gezira, Faculty of medicine

Locations

Wad Madani teaching Hospital

Wad Madani, Al Jazīrah, Sudan

Countries

Sudan

Other Identifiers

WADMAD-ICDS-2024-01

Identifier Type: -

Identifier Source: org_study_id