Traumatic Pneumothorax and HemothoraxNCT04863989
Emergency Small vs Large Tube Thoracostomy in Chest Trauma Patients.
A study testing tube thoracostomy in people with Traumatic Pneumothorax and Hemothorax, run by Assiut University.
Trial summary
To compare between small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube for the fear of obstruction (in hemomothorax) or ineffective drainage (in hemothorax, pneumothorax or hemo-pneumothorax) ,pain score or repositioning and need for thoracotomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Pneumothorax and Hemothorax
- What is being tested?
- tube thoracostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all chest trauma patients with significant hemothorax, pneumothorax or combined hemo-pneumothorax
Who cannot join
- any chest trauma patients undergoing thoracotomy or thoracic surgery for any other reason for example : diaphragmatic tear,flail chest or sternal fracture
Trial locations and contacts
No sites are listed yet.
About this study
To compare between small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube for the fear of obstruction (in hemomothorax) or ineffective drainage (in hemothorax, pneumothorax or hemo-pneumothorax) ,pain score or repositioning and need for thoracotomy.
Read the detailed description
To evacuate abnormal fluid and air, chest tubes are placed in the pleural space, either surgically or percutaneously. Therapeutic drainage of pleural conditions such as pneumothorax, hemothorax, empyema, chylothorax, and malignant effusions, as well as prophylaxis drainage of air, blood, and other fluids after chest surgery are the indications for chest tubes.
Closed water-seal chest drainage has been described in 1875 by Gotthard Bülau to treat an empyema, as an alternative to the standard rib resection and open tube drainage in the acute phase or rib excision (saucerization) in the chronic phase.
Bülau emphasized the necessity of negative intrapleural pressure for re-expansion of a collapsed lung in the setting of thoracic empyema although most surgeons in his time attributed deaths from thoracic empyema to infection and not superimposed respiratory compromise due to open pneumothorax .
He understood that closed water seal drainage could facilitate lung re-expansion via the patient's natural respiratory movements. Unfortunately, until mechanical ventilation was introduced, application of these principles was limited to the treatment of thoracic empyema.
During both the Second World War and the Korean one lung function restoration was the primary goal of thoracic wound treatment: emergency tube thoracostomy became extremely frequent in haemothorax and tension pneumothorax treatment. For the first time the drain was connected to a two-bottle water seal suction system since 1952 , synthetic ones, more flexible and easy to place, replaced metal tubes and modern three chamber thoracic drain, for a more efficient suction, were employed. New, flexible and plastic drains were widely used by the 1980s, they ranged between 6 and 40 French (F) in size. Since it was believed that smaller drains were less effective in adult medicine, being more prone to the risk of obstruction, the smaller ones (≤20 F) were commonly used in children, the bigger in adults,. In the last two decades, small-bore chest tubes (SBCT) have gained increasing popularity In traumatic pneumothorax or hemothorax the optimal tube size for an emergent thoracostomy is unknown. For the nonemergent management of patients with traumatic pneumothorax or hemothorax both small catheter tube thoracostomy and large-bore chest tube thoracostomy have been shown to work.
In stable trauma patients small catheter tube thoracostomy is effective and comparable with large catheter tube thoracostomy in managing chest trauma.
While the available evidence suggests that in resolving traumatic haemothoraces without additional complications small bore drains may be as effective as large bore drains, there is insufficient evidence currently available to recommend a change to standard practice (ie, large bore drains).
Inaba K , et al, 2012 concluded that chest tube size did not impact the clinically relevant outcomes tested for injured patients with chest trauma. There was no difference in the efficacy of drainage, need for additional tube drainage, or invasive procedures and rate of complications including retained hemothorax. Pain felt by patients at the site of insertion was not affected by tube size.
Most occurrences of traumatic pneumothorax (PTX) and hemothorax (HTX) can be managed non-operatively by means of chest tube thoracostomy. Although most guidelines for chest trauma recommend a large-bore chest tube, e.g., the 9th edition of the ATLSTM (Advanced Trauma Life Support) program recommends a 36 or 40 Fr tube, and the JATECTM (Japan Advanced Trauma Evaluation and Care) course recommends a 28 Fr or larger tube and choosing the tube size based on the patient's physique, these recommendations are mainly based on traditional clinical habits. These large-bore chest tubes may cause pain related to the insertion site and discomfort, especially in conscious patients. Smaller tubes were reported to reduce the pain associated with the tube insertion site in patients with pleural infection.
- Conditions
- Traumatic Pneumothorax and Hemothorax
- Being tested
- tube thoracostomy
- Medical subject headings
- Hemothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tube thoracostomyProcedure or surgery
insertion of intercostal tube for drainage of traumatic hemothorax or pneumothorax
| Study group | Role | What they receive |
|---|---|---|
| Small sized chest tube | Experimental | Insertion of small sized chest tube in patients with traumatic hemothorax, pneumothorax or hemopneumothorax. Receives: Procedure: tube thoracostomy |
| Large sized chest tube | Active comparator | insertion of large sized chest tube in patients with traumatic hemothorax, pneumothorax or hemopneumothorax. Receives: Procedure: tube thoracostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the number of patients who will have emergent small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube.
To compare the number of patients who will have emergent small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube.
Measured: baseline
Secondary outcomes (2)
Number of trauma patients who will have emergent small vs large thoracostomy tube regarding pain score
Number of trauma patients who will have emergent small vs large thoracostomy tube regarding pain score
Measured: baseline
Number of trauma patients who will have emergent small vs large thoracostomy tube regarding duration of tube insertion.
Number of trauma patients who will have emergent small vs large thoracostomy tube regarding duration of tube insertion.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Traumatic Pneumothorax and HemothoraxStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Mamdouh Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863989
- Sponsor's protocol ID
- small sized thoracostomy
- Status last verified
- Apr 2021
- First submitted
- 17 Sep 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cooke DT, David EA. Large-bore and small-bore chest tubes: types, function, and placement. Thorac Surg Clin. 2013 Feb;23(1):17-24, v. doi: 10.1016/j.thorsurg.2012.10.006.
PubMed 23206714Meyer JA. Gotthard Bulau and closed water-seal drainage for empyema, 1875-1891. Ann Thorac Surg. 1989 Oct;48(4):597-9. doi: 10.1016/s0003-4975(10)66876-2.
PubMed 2679468Van Schil PE. Thoracic drainage and the contribution of Gotthard Bulau. Ann Thorac Surg. 1997 Dec;64(6):1876. No abstract available.
PubMed 9436605Monaghan SF, Swan KG. Tube thoracostomy: the struggle to the "standard of care". Ann Thorac Surg. 2008 Dec;86(6):2019-22. doi: 10.1016/j.athoracsur.2008.08.006.
PubMed 19022041HOWE BE Jr. Evaluation of chest suction with an artificial thorax. Surg Forum. 1951:1-7. No abstract available.
PubMed 14931188Miller KS, Sahn SA. Chest tubes. Indications, technique, management and complications. Chest. 1987 Feb;91(2):258-64. doi: 10.1378/chest.91.2.258. No abstract available.
PubMed 3542404Filosso PL, Sandri A, Guerrera F, Ferraris A, Marchisio F, Bora G, Costardi L, Solidoro P, Ruffini E, Oliaro A. When size matters: changing opinion in the management of pleural space-the rise of small-bore pleural catheters. J Thorac Dis. 2016 Jul;8(7):E503-10. doi: 10.21037/jtd.2016.06.25.
PubMed 27499983Tanizaki S, Maeda S, Sera M, Nagai H, Hayashi M, Azuma H, Kano KI, Watanabe H, Ishida H. Small tube thoracostomy (20-22 Fr) in emergent management of chest trauma. Injury. 2017 Sep;48(9):1884-1887. doi: 10.1016/j.injury.2017.06.021. Epub 2017 Jun 23.
PubMed 28673640Rivera L, O'Reilly EB, Sise MJ, Norton VC, Sise CB, Sack DI, Swanson SM, Iman RB, Paci GM, Antevil JL. Small catheter tube thoracostomy: effective in managing chest trauma in stable patients. J Trauma. 2009 Feb;66(2):393-9. doi: 10.1097/TA.0b013e318173f81e.
PubMed 19204512Towards evidence-based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 4: does size matter? Chest drains in haemothorax following trauma. Emerg Med J. 2013 Nov;30(11):965-7. doi: 10.1136/emermed-2013-203139.4.
PubMed 24142946Inaba K, Lustenberger T, Recinos G, Georgiou C, Velmahos GC, Brown C, Salim A, Demetriades D, Rhee P. Does size matter? A prospective analysis of 28-32 versus 36-40 French chest tube size in trauma. J Trauma Acute Care Surg. 2012 Feb;72(2):422-7. doi: 10.1097/TA.0b013e3182452444.
PubMed 22327984ATLS Subcommittee; American College of Surgeons' Committee on Trauma; International ATLS working group. Advanced trauma life support (ATLS(R)): the ninth edition. J Trauma Acute Care Surg. 2013 May;74(5):1363-6. doi: 10.1097/TA.0b013e31828b82f5. No abstract available.
PubMed 23609291
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Small vs Large Tube Thoracostomy in Chest Trauma Patients.
- ClinicalTrials.gov ID
- NCT04863989
- Acronym / sponsor ID
- small sized thoracostomy
- Conditions
- Traumatic Pneumothorax and Hemothorax
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Apr 2021 (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.
To compare between small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube for the fear of obstruction (in hemomothorax) or ineffective drainage (in hemothorax, pneumothorax or hemo-pneumothorax) ,pain score or repositioning and need for thoracotomy.
Detailed description
To evacuate abnormal fluid and air, chest tubes are placed in the pleural space, either surgically or percutaneously. Therapeutic drainage of pleural conditions such as pneumothorax, hemothorax, empyema, chylothorax, and malignant effusions, as well as prophylaxis drainage of air, blood, and other fluids after chest surgery are the indications for chest tubes.
Closed water-seal chest drainage has been described in 1875 by Gotthard Bülau to treat an empyema, as an alternative to the standard rib resection and open tube drainage in the acute phase or rib excision (saucerization) in the chronic phase.
Bülau emphasized the necessity of negative intrapleural pressure for re-expansion of a collapsed lung in the setting of thoracic empyema although most surgeons in his time attributed deaths from thoracic empyema to infection and not superimposed respiratory compromise due to open pneumothorax .
He understood that closed water seal drainage could facilitate lung re-expansion via the patient's natural respiratory movements. Unfortunately, until mechanical ventilation was introduced, application of these principles was limited to the treatment of thoracic empyema.
During both the Second World War and the Korean one lung function restoration was the primary goal of thoracic wound treatment: emergency tube thoracostomy became extremely frequent in haemothorax and tension pneumothorax treatment. For the first time the drain was connected to a two-bottle water seal suction system since 1952 , synthetic ones, more flexible and easy to place, replaced metal tubes and modern three chamber thoracic drain, for a more efficient suction, were employed. New, flexible and plastic drains were widely used by the 1980s, they ranged between 6 and 40 French (F) in size. Since it was believed that smaller drains were less effective in adult medicine, being more prone to the risk of obstruction, the smaller ones (≤20 F) were commonly used in children, the bigger in adults,. In the last two decades, small-bore chest tubes (SBCT) have gained increasing popularity In traumatic pneumothorax or hemothorax the optimal tube size for an emergent thoracostomy is unknown. For the nonemergent management of patients with traumatic pneumothorax or hemothorax both small catheter tube thoracostomy and large-bore chest tube thoracostomy have been shown to work.
In stable trauma patients small catheter tube thoracostomy is effective and comparable with large catheter tube thoracostomy in managing chest trauma.
While the available evidence suggests that in resolving traumatic haemothoraces without additional complications small bore drains may be as effective as large bore drains, there is insufficient evidence currently available to recommend a change to standard practice (ie, large bore drains).
Inaba K , et al, 2012 concluded that chest tube size did not impact the clinically relevant outcomes tested for injured patients with chest trauma. There was no difference in the efficacy of drainage, need for additional tube drainage, or invasive procedures and rate of complications including retained hemothorax. Pain felt by patients at the site of insertion was not affected by tube size.
Most occurrences of traumatic pneumothorax (PTX) and hemothorax (HTX) can be managed non-operatively by means of chest tube thoracostomy. Although most guidelines for chest trauma recommend a large-bore chest tube, e.g., the 9th edition of the ATLSTM (Advanced Trauma Life Support) program recommends a 36 or 40 Fr tube, and the JATECTM (Japan Advanced Trauma Evaluation and Care) course recommends a 28 Fr or larger tube and choosing the tube size based on the patient's physique, these recommendations are mainly based on traditional clinical habits. These large-bore chest tubes may cause pain related to the insertion site and discomfort, especially in conscious patients. Smaller tubes were reported to reduce the pain associated with the tube insertion site in patients with pleural infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small sized chest tube | Experimental | Procedure: tube thoracostomyInsertion of small sized chest tube in patients with traumatic hemothorax, pneumothorax or hemopneumothorax. |
| Large sized chest tube | Active comparator | Procedure: tube thoracostomyinsertion of large sized chest tube in patients with traumatic hemothorax, pneumothorax or hemopneumothorax. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all chest trauma patients with significant hemothorax, pneumothorax or combined hemo-pneumothorax
Key exclusion criteria (1 listed)
- any chest trauma patients undergoing thoracotomy or thoracic surgery for any other reason for example : diaphragmatic tear,flail chest or sternal fracture
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 |
|---|---|---|
| tube thoracostomyinsertion of intercostal tube for drainage of traumatic hemothorax or pneumothorax | Procedure or surgery | Large sized chest tube, Small sized chest tube |
Primary outcome
To compare the number of patients who will have emergent small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube.
Time frame: baseline
To compare the number of patients who will have emergent small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube.
2 secondary outcomes
Number of trauma patients who will have emergent small vs large thoracostomy tube regarding pain score
Time frame: baseline
Number of trauma patients who will have emergent small vs large thoracostomy tube regarding duration of tube insertion.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 23206714Cooke DT, David EA. Large-bore and small-bore chest tubes: types, function, and placement. Thorac Surg Clin. 2013 Feb;23(1):17-24, v. doi: 10.1016/j.thorsurg.2012.10.006.
- Background: PubMed 2679468Meyer JA. Gotthard Bulau and closed water-seal drainage for empyema, 1875-1891. Ann Thorac Surg. 1989 Oct;48(4):597-9. doi: 10.1016/s0003-4975(10)66876-2.
- Background: PubMed 9436605Van Schil PE. Thoracic drainage and the contribution of Gotthard Bulau. Ann Thorac Surg. 1997 Dec;64(6):1876. No abstract available.
- Background: PubMed 19022041Monaghan SF, Swan KG. Tube thoracostomy: the struggle to the "standard of care". Ann Thorac Surg. 2008 Dec;86(6):2019-22. doi: 10.1016/j.athoracsur.2008.08.006.
- Background: PubMed 14931188HOWE BE Jr. Evaluation of chest suction with an artificial thorax. Surg Forum. 1951:1-7. No abstract available.
- Background: PubMed 3542404Miller KS, Sahn SA. Chest tubes. Indications, technique, management and complications. Chest. 1987 Feb;91(2):258-64. doi: 10.1378/chest.91.2.258. No abstract available.
- Background: PubMed 27499983Filosso PL, Sandri A, Guerrera F, Ferraris A, Marchisio F, Bora G, Costardi L, Solidoro P, Ruffini E, Oliaro A. When size matters: changing opinion in the management of pleural space-the rise of small-bore pleural catheters. J Thorac Dis. 2016 Jul;8(7):E503-10. doi: 10.21037/jtd.2016.06.25.
- Background: PubMed 28673640Tanizaki S, Maeda S, Sera M, Nagai H, Hayashi M, Azuma H, Kano KI, Watanabe H, Ishida H. Small tube thoracostomy (20-22 Fr) in emergent management of chest trauma. Injury. 2017 Sep;48(9):1884-1887. doi: 10.1016/j.injury.2017.06.021. Epub 2017 Jun 23.
- Background: PubMed 19204512Rivera L, O'Reilly EB, Sise MJ, Norton VC, Sise CB, Sack DI, Swanson SM, Iman RB, Paci GM, Antevil JL. Small catheter tube thoracostomy: effective in managing chest trauma in stable patients. J Trauma. 2009 Feb;66(2):393-9. doi: 10.1097/TA.0b013e318173f81e.
- Background: PubMed 24142946Towards evidence-based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 4: does size matter? Chest drains in haemothorax following trauma. Emerg Med J. 2013 Nov;30(11):965-7. doi: 10.1136/emermed-2013-203139.4.
- Background: PubMed 22327984Inaba K, Lustenberger T, Recinos G, Georgiou C, Velmahos GC, Brown C, Salim A, Demetriades D, Rhee P. Does size matter? A prospective analysis of 28-32 versus 36-40 French chest tube size in trauma. J Trauma Acute Care Surg. 2012 Feb;72(2):422-7. doi: 10.1097/TA.0b013e3182452444.
- Background: PubMed 23609291ATLS Subcommittee; American College of Surgeons' Committee on Trauma; International ATLS working group. Advanced trauma life support (ATLS(R)): the ninth edition. J Trauma Acute Care Surg. 2013 May;74(5):1363-6. doi: 10.1097/TA.0b013e31828b82f5. No abstract available.
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.
Questions about this trial
What is this clinical trial studying?
A study testing tube thoracostomy in people with Traumatic Pneumothorax and Hemothorax, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact amr mohamed mamdouh, resident (+201000566770, amrmamdouh_95@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the number of patients who will have emergent small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube. (time frame: baseline). 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 NCT04863989, which also lists 12 linked publications.
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 28 Apr 2021.