PneumothoraxNCT06683976
Evaluating Improvised Chest Drainage Techniques in Conflict Zones
An observational study of Pneumothorax and Hemothorax, run by Sudan Medical Specialization Board at 1 site in Sudan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pneumothorax, Hemothorax, Thoracic Trauma
- Type of treatment
- Injection or infusion
- How many people
- 180 participants
- Where
- 1 siteSudan
- Study dates
- 1 Jun 2023to 10 Dec 2023
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- 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
- Medical subject headings
- Pneumothorax, Hemothorax, Flail Chest, Hemopneumothorax, Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 72 hours post-drainage
Secondary outcomes (2)
Rate of Drainage-Related Infections
Number of participants with infections directly associated with the chest drainage procedure, including pleural or wound infections, documented by clinical signs and laboratory findings.
Measured: Up to 30 days post-procedure
Median Length of Hospital Stay
Median number of days from admission to discharge for each participant, allowing for the assessment of recovery duration associated with each drainage method.
Measured: From admission to discharge (typically within 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Sudan Medical Specialization Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alsadig Suliman, Sudan Medical Specialization Board
- Investigators
- Hassan Ali Musa, Consultant, Study chair, University of Gezira, Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683976
- Sponsor's protocol ID
- WADMAD-ICDS-2024-01
- Status last verified
- Jan 2025
- First submitted
- 7 Nov 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly due to several considerations. First, the data includes sensitive personal health information, which must be protected to comply with privacy regulations and ethical standards. Additionally, the study is conducted in a low-resource setting, where data management and sharing capabilities may be limited. Ensuring the confidentiality and anonymity of participants is paramount, and sharing IPD could compromise these ethical obligations. Finally, the data will be used exclusively for the purpose of this study to inform clinical practice within the context of the local healthcare system, rather than for broader dissemination.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06683976
- Acronym / sponsor ID
- WADMAD-ICDS-2024-01
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sudan Medical Specialization BoardOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Rate of Drainage-Related Infections
Time frame: Up to 30 days post-procedure
Median Length of Hospital Stay
Time frame: From admission to discharge (typically within 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly due to several considerations. First, the data includes sensitive personal health information, which must be protected to comply with privacy regulations and ethical standards. Additionally, the study is conducted in a low-resource setting, where data management and sharing capabilities may be limited. Ensuring the confidentiality and anonymity of participants is paramount, and sharing IPD could compromise these ethical obligations. Finally, the data will be used exclusively for the purpose of this study to inform clinical practice within the context of the local healthcare system, rather than for broader dissemination.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Ali Musa, Consultant study chair
University of Gezira, Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax and Hemothorax, run by Sudan Medical Specialization Board at 1 site in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Successful Lung Re-expansion (time frame: Within 72 hours post-drainage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.