Traumatic Hemothorax and PneumothoraxNCT02344524
Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain
A study testing Intercostal drainage in people with Traumatic Hemothorax and Pneumothorax, run by Delhi University at 1 site in India.
Trial summary
The purpose of this trial is to study the role of small bore chest drains in draining traumatic hemothorax and pneumothorax. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Traumatic Hemothorax and Pneumothorax
- What is being tested?
- Intercostal drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2012to Apr 2014
- Phase
- Interventional
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with traumatic hemothorax, pneumothorax and hemopneumothorax
Who cannot join
- Patients with tension pneumothorax
- Patients requiring emergency thoracotomy
- Patients who had undergone chest drain insertion elsewhere
- Patients lost to follow up
Trial locations and contacts
1 site in 1 country.
India1 site
University College of Medical Sciences & GTB Hospital
New Delhi, National Capital Territory of Delhi, 110095
About this study
Official title: Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain- a Randomized Controlled Trial
The purpose of this trial is to study the role of small bore chest drains in draining traumatic hemothorax and pneumothorax.
Read the detailed description
The precise role of small bore chest drains in treating post traumatic pleural collections, especially hemothorax is not well established. This trial is conducted to study the efficacy and safety profile of small bore chest drains in trauma patients with hemothorax and pneumothorax.
- Conditions
- Traumatic Hemothorax and Pneumothorax
- Being tested
- Intercostal drainage
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal drainageDevice
Small bore chest drains are inserted by modified Seldinger's technique. Large bore chest drains are inserted by blunt dissection technique.
| Study group | Role | What they receive |
|---|---|---|
| Small bore chest drain | Experimental | Intercostal drainage for traumatic hemothorax and pneumothorax using small bore chest drain Receives: Device: Intercostal drainage |
| Large bore chest drain | Active comparator | Intercostal drainage for traumatic hemothorax and pneumothorax using large bore chest drain Receives: Device: Intercostal drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Complete drainage of traumatic hemothorax and pneumothorax
Measured: 7 days (plus or minus 5 days)
Secondary outcomes (5)
Procedure time
Time taken for inserting the chest drain
Measured: At the time of the intervention
Iatrogenic injuries
Insertion related complications
Measured: At the time of the intervention
Resolution time
Time taken for complete drainage of traumatic hemothorax and pneumothorax
Measured: 7 days (plus or minus 5 days)
Wound healing time
Time taken for the chest drain site wound to heal
Measured: 10 days (plus or minus 5 days)
Catheter sepsis
Identification of infective organisms from catheter tip based on culture following chest drain removal
Measured: 7 days (plus or minus 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Hemothorax and 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delhi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil Kumar, Delhi University
- Investigators
- Sunil Kumar, MS, Principal investigator, Delhi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344524
- Sponsor's protocol ID
- CTRI/2014/07/004795
- Status last verified
- Jan 2015
- First submitted
- 12 Jan 2015
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Yi JH, Liu HB, Zhang M, Wu JS, Yang JX, Chen JM, Xu SX, Wang JA. Management of traumatic hemothorax by closed thoracic drainage using a central venous catheter. J Zhejiang Univ Sci B. 2012 Jan;13(1):43-8. doi: 10.1631/jzus.B1100161.
PubMed 22205619
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02344524
- Acronym / sponsor ID
- CTRI/2014/07/004795
- Conditions
- Traumatic Hemothorax and Pneumothorax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Delhi UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Jan 2015 (estimated)
- 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.
The purpose of this trial is to study the role of small bore chest drains in draining traumatic hemothorax and pneumothorax.
Detailed description
The precise role of small bore chest drains in treating post traumatic pleural collections, especially hemothorax is not well established. This trial is conducted to study the efficacy and safety profile of small bore chest drains in trauma patients with hemothorax and pneumothorax.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small bore chest drain | Experimental | Device: Intercostal drainageIntercostal drainage for traumatic hemothorax and pneumothorax using small bore chest drain |
| Large bore chest drain | Active comparator | Device: Intercostal drainageIntercostal drainage for traumatic hemothorax and pneumothorax using large bore chest drain |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with traumatic hemothorax, pneumothorax and hemopneumothorax
Key exclusion criteria (4 listed)
- Patients with tension pneumothorax
- Patients requiring emergency thoracotomy
- Patients who had undergone chest drain insertion elsewhere
- Patients lost to follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intercostal drainageSmall bore chest drains are inserted by modified Seldinger's technique. Large bore chest drains are inserted by blunt dissection technique. | Device | Large bore chest drain, Small bore chest drain |
Primary outcome
Success rate
Time frame: 7 days (plus or minus 5 days)
Complete drainage of traumatic hemothorax and pneumothorax
5 secondary outcomes
Procedure time
Time frame: At the time of the intervention
Iatrogenic injuries
Time frame: At the time of the intervention
Resolution time
Time frame: 7 days (plus or minus 5 days)
Wound healing time
Time frame: 10 days (plus or minus 5 days)
Catheter sepsis
Time frame: 7 days (plus or minus 5 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 26 Jan 2015.
- Results publication: PubMed 22205619Yi JH, Liu HB, Zhang M, Wu JS, Yang JX, Chen JM, Xu SX, Wang JA. Management of traumatic hemothorax by closed thoracic drainage using a central venous catheter. J Zhejiang Univ Sci B. 2012 Jan;13(1):43-8. doi: 10.1631/jzus.B1100161.
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.
Sunil Kumar, MS principal investigator
Delhi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intercostal drainage in people with Traumatic Hemothorax and Pneumothorax, run by Delhi University at 1 site in India.
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 1 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 26 Jan 2015. 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 India. 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?
Success rate (time frame: 7 days (plus or minus 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02344524, which also lists 1 linked publication.
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 26 Jan 2015.