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Completed

NCT Number: NCT06683976

Evaluating Improvised Chest Drainage Techniques in Conflict Zones

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wad Madani teaching Hospital

Wad Madani, Al Jazirah, Sudan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Patients With Successful Lung Re-expansion

    Time frame: 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 outcomes

  1. Rate of Drainage-Related Infections

    Time frame: 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.

  2. Median Length of Hospital Stay

    Time frame: 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.

Other outcomes

  1. Patient Satisfaction Score at Discharge

    Time frame: At discharge (up to 30 days post-procedure)

    Patient satisfaction score assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied) at discharge, indicating the participant's perceived comfort and effectiveness of the chest drainage method used.

Sponsors and collaborators

Lead sponsor

Sudan Medical Specialization Board

Other Gov

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 12, 2024
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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