Evaluating Improvised Chest Drainage Techniques in Conflict Zones

NCT06683976 | Completed DMC

• 1 other identifier: WADMAD-ICDS-2024-01
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Successful Lung Re-expansion

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

  Within 72 hours post-drainage

Secondary Outcomes (2)

• Rate of Drainage-Related Infections

  Up to 30 days post-procedure

• Median Length of Hospital Stay

  From admission to discharge (typically within 30 days)

Other Outcomes (1)

• Patient Satisfaction Score at Discharge

  At discharge (up to 30 days post-procedure)

Study Arms (2)

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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sudan Medical Specialization Board: lead

Study Sites (1)

Wad Madani teaching Hospital

Wad Madani, Al Jazirah, Sudan

Location

MeSH Terms

Conditions

Pneumothorax; Hemothorax; Flail Chest; Hemopneumothorax; Thoracic Injuries

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Hassan Ali Musa, Consultant

  University of Gezira, Faculty of medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 10, 2023
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SU (1)