Pneumothorax; AcuteNCT04188938
Occult Pneumothorax in Patients With Blunt or Penetrating Trauma
An observational study of Pneumothorax; Acute and Trauma Chest, run by European University of Lefke.
Trial summary
Pneumothorax is a common life-threatening complication, frequently seen in patients who have been admitted to the emergency department and intensive care unit. This study aimed to describe the features of patients with pneumothorax due to blunt or penetrating trauma. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pneumothorax; Acute, Trauma Chest
- What is being tested?
- Evaluation of occult pneumothorax in who had a blunt or penetrating chest trauma
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 19 Apr 2011
- How long will I take part?
- 1 Year
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive participants over the age of 16 who were admitted to the ED between the 1st of January 2008 and 31st of December 2010 due to multi-trauma, consulted by a thoracic surgeon and underwent both CXR and CT were included in the study.
Who may be able to join
- >16 years of age consulted by a thoracic surgeon had a multi-trauma underwent both chest x ray and computed tomography
Who cannot join
- <16 years of age not consulted by a thoracic surgeon did not have a multi-trauma did not undergo both chest x ray and computed tomography
About this study
Official title: Occult Pneumothorax in Patients With Blunt or Penetrating Trauma: A Descriptive, Cross-sectional Study
Pneumothorax is a common life-threatening complication, frequently seen in patients who have been admitted to the emergency department and intensive care unit. This study aimed to describe the features of patients with pneumothorax due to blunt or penetrating trauma. A total of 615 patients admitted to the emergency department between January 2008 and December 2010 due to multi-trauma, and underwent both chest x-ray and computed chest tomography were included in the study. There were 157 patients with a diagnosis of pneumothorax. Fifty-five of them were excluded because of the eligible criteria. The final study population included 105 patients. The computed chest tomography reading was considered as the gold standard for the occult pneumothorax diagnosis. Data on patient characteristics, trauma types, accompanied traumas, etiology of the chest trauma, and chest x-ray, and computed chest tomography results were recorded.
Read the detailed description
Thoracic injuries are the third most common cause of trauma-related morbidity/mortality and hospitalization after heart disease and malignancies. At least 25% of blunt traumatic deaths are a direct consequence of chest trauma. Additionally, rib fracture and pneumothorax are the first two most frequent blunt thoracic traumas, respectively.
Pneumothorax (PTX) is a common life-threatening complication and frequently seen in patients who have been admitted to the Emergency Department (ED) and Intense Care Units (ICU). Some traumatic PTXs are clinically and radiologically silent, not identified during the initial assessment and cannot be visible on supine chest x-ray (CXR), but later diagnosed by computed tomography (CT). This type of PTX is called occult pneumothorax (OPTX) and has been found in 30-55% of chest trauma cases. The clinical diagnosis of PTX is incorrect in approximately 30% of all traumatic cases. Besides, it has been stated that PTX has the potential to elevate the mortality rate in patients with trauma if it is not quickly managed.
On the other hand, small or medium undetected PTX usually is not life-threatening. However, delays in the diagnosis and management may result in a rapid progression of OPTX to tension PTX and lead to severe dyspnea and even death. Therefore, early detection is crucial and may influence the evaluation and management of PTX and probably be a lifesaving action.
The initial diagnostic screening test of PTX is usually CXR. However, studies reported that CXR is an insensitive and unreliable test. When the chest x-ray of the patient is acquired in a supine position, even if all of the symptoms related to pneumothorax are present (since the air is not located at the apical pulmonary region), there may not be an image consistent with PTX. For this reason, although CXR is usually used for many thoracic injuries as a screening test, it may miss the diagnosis of some thoracic injuries, including rib fractures, pulmonary contusions, and OPTX.
On the other hand, the role of CT in the assessment of chest injuries has expanded considerably in the management of both blunt and penetrating traumas. The increasing use of CT in the evaluation and management of patients with chest trauma has led to correct and sensitive identification of undetected injuries, including OPTX.
There are limited, but conflicting data about the ideal management type of OPTX in blunt trauma. Some physicians prefer the insertion of a tube thoracostomy (TT) for all OPTX patients, while others favor close observation without chest drainage. Physicians who prefer to insert a TT claim that an untreated OPTX can rapidly evolve into a tension PTX with catastrophic consequences. However, those who favor close observation without TT claim that patients should not be subjected to unnecessary invasive processes.
This study aimed to identify the incidence of OPTX in patients with blunt or penetrating trauma.
This study is a single-center (Emergency Department of Ankara Training and Research Hospital) retrospective analysis of trauma registry data. All consecutive participants over the age of 16 who were admitted to the ED between the 1st of January 2008 and 31st of December 2010 due to multi-trauma, consulted by a thoracic surgeon and underwent both CXR and CT were included in the study. Files of 615 patients who were admitted to ED with a thoracic trauma were reviewed (2008; n=187, 2009; n=168, and 2010; n=260). Patients who had no simultaneous CXR+CT or no pathology in their CT were excluded (n=458). Also, patients not referred to a chest surgeon, and those referred to some other hospital were excluded (n=52). Data for the remaining 105 patients were analyzed. The CT interpretation was considered as the gold standard for the PTX diagnosis. Electronic medical records were then searched for patient characteristics (age and gender), trauma types (blunt or penetrating), accompanied traumas (intra-cerebral and intra-abdominal systems), etiology of the chest trauma (traffic accidents, falls, other), and CXR and CT results. Additionally, the intervention types (thoracostomy tube insertion, thoracentesis, no intervention) during the early phase of the management were recorded. All chest x-rays were performed on the supine position based on the trauma protocol of the hospital. Cases missed by the CXR but identified in the CT were defined as OPTX. Using the web-based Java applet developed by Russ Lenth (https://homepage.divms.uiowa.edu/~rlenth/Power/), a post hoc sample size calculation was performed based on a 7% expected prevalence of OPTX. Given an infinite population and a margin of error of 5%, a sample size of 100 cases is required to estimate OPTX in the study population with a confidence interval of 95%. Statistical analysis was performed with the Statistical Package for the Social Sciences version 22 (SPSS, IBM, Armonk, NY, USA). The 'number (n),' 'percentage (%),' 'mean,' and 'standard deviation (SD)' was given for the descriptive statistics. Pearson Chi-Square or Fisher's exact tests used to compare categorical data. Age between groups was analyzed using the Mann-Whitney U test. Logistic regression analysis was applied to check for independent factors affecting the presence of OPTX. The results were evaluated with a confidence interval of 95%, and the level of significance, p, was set at <0.05.
- Conditions
- Pneumothorax; Acute, Trauma Chest
- Being tested
- Evaluation of occult pneumothorax in who had a blunt or penetrating chest trauma
- Keywords
- Trauma, Thorax, Emergency, Pneumothorax
- Medical subject headings
- Pneumothorax, Thoracic Injuries, Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of occult pneumothorax in who had a blunt or penetrating chest traumaOther
Also called Trauma, Pneumothorax
| Study group | Role | What they receive |
|---|---|---|
| Occult pneumothorax in trauma patients | Age>16, multi-trauma, consulted thoracic surgeon, underwent CXR- CT. Receives: Other: Evaluation of occult pneumothorax in who had a blunt or penetrating chest trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occult Pneumothorax in Patients with Blunt or Penetrating Thoracic Trauma
Patient Registry
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start1 Jan 2008
- Primary completion31 Dec 2010
- Study completion19 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Pneumothorax; AcuteStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 105 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- European University of Lefke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semra Aslay, European University of Lefke
- Investigators
- Semra Aslay, M.D., Study director, European University of Lefke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188938
- Sponsor's protocol ID
- Pneumothorax
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participating data
Publications
Wilson H, Ellsmere J, Tallon J, Kirkpatrick A. Occult pneumothorax in the blunt trauma patient: tube thoracostomy or observation? Injury. 2009 Sep;40(9):928-31. doi: 10.1016/j.injury.2009.04.005. Epub 2009 Jun 17.
PubMed 19539280Soldati G, Testa A, Sher S, Pignataro G, La Sala M, Silveri NG. Occult traumatic pneumothorax: diagnostic accuracy of lung ultrasonography in the emergency department. Chest. 2008 Jan;133(1):204-11. doi: 10.1378/chest.07-1595. Epub 2007 Oct 9.
PubMed 17925411Kunitake RC, Kornblith LZ, Cohen MJ, Callcut RA. Trauma Early Mortality Prediction Tool (TEMPT) for assessing 28-day mortality. Trauma Surg Acute Care Open. 2018 Jan 8;3(1):e000131. doi: 10.1136/tsaco-2017-000131. eCollection 2018.
PubMed 29766125Ding W, Shen Y, Yang J, He X, Zhang M. Diagnosis of pneumothorax by radiography and ultrasonography: a meta-analysis. Chest. 2011 Oct;140(4):859-866. doi: 10.1378/chest.10-2946. Epub 2011 May 5.
PubMed 21546439Ball CG, Kirkpatrick AW, Laupland KB, Fox DL, Litvinchuk S, Dyer DM, Anderson IB, Hameed SM, Kortbeek JB, Mulloy R. Factors related to the failure of radiographic recognition of occult posttraumatic pneumothoraces. Am J Surg. 2005 May;189(5):541-6; discussion 546. doi: 10.1016/j.amjsurg.2005.01.018.
PubMed 15862493Chan YH, Zeng YZ, Wu HC, Wu MC, Sun HM. Effective Pneumothorax Detection for Chest X-Ray Images Using Local Binary Pattern and Support Vector Machine. J Healthc Eng. 2018 Apr 3;2018:2908517. doi: 10.1155/2018/2908517. eCollection 2018.
PubMed 29849996Holmes JF, Brant WE, Bogren HG, London KL, Kuppermann N. Prevalence and importance of pneumothoraces visualized on abdominal computed tomographic scan in children with blunt trauma. J Trauma. 2001 Mar;50(3):516-20. doi: 10.1097/00005373-200103000-00017.
PubMed 11265032Lee LK, Rogers AJ, Ehrlich PF, Kwok M, Sokolove PE, Blumberg S, Kooistra J, Olsen CS, Wootton-Gorges S, Cooper A, Kuppermann N, Holmes JF; Pediatric Emergency Care Applied Research Network (PECARN). Occult pneumothoraces in children with blunt torso trauma. Acad Emerg Med. 2014 Apr;21(4):440-8. doi: 10.1111/acem.12344.
PubMed 24730407Akoglu H, Akoglu EU, Evman S, Akoglu T, Denizbasi A, Guneysel O, Onur O, Onur E. Utility of cervical spinal and abdominal computed tomography in diagnosing occult pneumothorax in patients with blunt trauma: Computed tomographic imaging protocol matters. J Trauma Acute Care Surg. 2012 Oct;73(4):874-9. doi: 10.1097/TA.0b013e3182569ff2.
PubMed 22835995Plurad D, Green D, Demetriades D, Rhee P. The increasing use of chest computed tomography for trauma: is it being overutilized? J Trauma. 2007 Mar;62(3):631-5. doi: 10.1097/TA.0b013e31802bf009.
PubMed 17414339Enderson BL, Abdalla R, Frame SB, Casey MT, Gould H, Maull KI. Tube thoracostomy for occult pneumothorax: a prospective randomized study of its use. J Trauma. 1993 Nov;35(5):726-9; discussion 729-30.
PubMed 8230337Ouellet JF, Trottier V, Kmet L, Rizoli S, Laupland K, Ball CG, Sirois M, Kirkpatrick AW. The OPTICC trial: a multi-institutional study of occult pneumothoraces in critical care. Am J Surg. 2009 May;197(5):581-6. doi: 10.1016/j.amjsurg.2008.12.007.
PubMed 19306978Ball CG, Kirkpatrick AW, Feliciano DV. The occult pneumothorax: what have we learned? Can J Surg. 2009 Oct;52(5):E173-9.
PubMed 19865549Matsumoto S, Kishikawa M, Hayakawa K, Narumi A, Matsunami K, Kitano M. A method to detect occult pneumothorax with chest radiography. Ann Emerg Med. 2011 Apr;57(4):378-81. doi: 10.1016/j.annemergmed.2010.08.012. Epub 2010 Sep 22.
PubMed 20864214Ball CG, Kirkpatrick AW, Fox DL, Laupland KB, Louis LJ, Andrews GD, Dunlop MP, Kortbeek JB, Nicolaou S. Are occult pneumothoraces truly occult or simply missed? J Trauma. 2006 Feb;60(2):294-8 discussion 298-9. doi: 10.1097/01.ta.0000202462.96207.18.
PubMed 16508485
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occult Pneumothorax in Patients With Blunt or Penetrating Trauma: A Descriptive, Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04188938
- Acronym / sponsor ID
- Pneumothorax
- Conditions
- Pneumothorax; Acute, Trauma Chest
- Keywords
- Trauma, Thorax, Emergency, Pneumothorax
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- European University of LefkeUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 19 Apr 2011 (actual)
- First posted
- 6 Dec 2019 (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.
Pneumothorax is a common life-threatening complication, frequently seen in patients who have been admitted to the emergency department and intensive care unit. This study aimed to describe the features of patients with pneumothorax due to blunt or penetrating trauma. A total of 615 patients admitted to the emergency department between January 2008 and December 2010 due to multi-trauma, and underwent both chest x-ray and computed chest tomography were included in the study. There were 157 patients with a diagnosis of pneumothorax. Fifty-five of them were excluded because of the eligible criteria. The final study population included 105 patients. The computed chest tomography reading was considered as the gold standard for the occult pneumothorax diagnosis. Data on patient characteristics, trauma types, accompanied traumas, etiology of the chest trauma, and chest x-ray, and computed chest tomography results were recorded.
Detailed description
Thoracic injuries are the third most common cause of trauma-related morbidity/mortality and hospitalization after heart disease and malignancies. At least 25% of blunt traumatic deaths are a direct consequence of chest trauma. Additionally, rib fracture and pneumothorax are the first two most frequent blunt thoracic traumas, respectively.
Pneumothorax (PTX) is a common life-threatening complication and frequently seen in patients who have been admitted to the Emergency Department (ED) and Intense Care Units (ICU). Some traumatic PTXs are clinically and radiologically silent, not identified during the initial assessment and cannot be visible on supine chest x-ray (CXR), but later diagnosed by computed tomography (CT). This type of PTX is called occult pneumothorax (OPTX) and has been found in 30-55% of chest trauma cases. The clinical diagnosis of PTX is incorrect in approximately 30% of all traumatic cases. Besides, it has been stated that PTX has the potential to elevate the mortality rate in patients with trauma if it is not quickly managed.
On the other hand, small or medium undetected PTX usually is not life-threatening. However, delays in the diagnosis and management may result in a rapid progression of OPTX to tension PTX and lead to severe dyspnea and even death. Therefore, early detection is crucial and may influence the evaluation and management of PTX and probably be a lifesaving action.
The initial diagnostic screening test of PTX is usually CXR. However, studies reported that CXR is an insensitive and unreliable test. When the chest x-ray of the patient is acquired in a supine position, even if all of the symptoms related to pneumothorax are present (since the air is not located at the apical pulmonary region), there may not be an image consistent with PTX. For this reason, although CXR is usually used for many thoracic injuries as a screening test, it may miss the diagnosis of some thoracic injuries, including rib fractures, pulmonary contusions, and OPTX.
On the other hand, the role of CT in the assessment of chest injuries has expanded considerably in the management of both blunt and penetrating traumas. The increasing use of CT in the evaluation and management of patients with chest trauma has led to correct and sensitive identification of undetected injuries, including OPTX.
There are limited, but conflicting data about the ideal management type of OPTX in blunt trauma. Some physicians prefer the insertion of a tube thoracostomy (TT) for all OPTX patients, while others favor close observation without chest drainage. Physicians who prefer to insert a TT claim that an untreated OPTX can rapidly evolve into a tension PTX with catastrophic consequences. However, those who favor close observation without TT claim that patients should not be subjected to unnecessary invasive processes.
This study aimed to identify the incidence of OPTX in patients with blunt or penetrating trauma.
This study is a single-center (Emergency Department of Ankara Training and Research Hospital) retrospective analysis of trauma registry data. All consecutive participants over the age of 16 who were admitted to the ED between the 1st of January 2008 and 31st of December 2010 due to multi-trauma, consulted by a thoracic surgeon and underwent both CXR and CT were included in the study. Files of 615 patients who were admitted to ED with a thoracic trauma were reviewed (2008; n=187, 2009; n=168, and 2010; n=260). Patients who had no simultaneous CXR+CT or no pathology in their CT were excluded (n=458). Also, patients not referred to a chest surgeon, and those referred to some other hospital were excluded (n=52). Data for the remaining 105 patients were analyzed. The CT interpretation was considered as the gold standard for the PTX diagnosis. Electronic medical records were then searched for patient characteristics (age and gender), trauma types (blunt or penetrating), accompanied traumas (intra-cerebral and intra-abdominal systems), etiology of the chest trauma (traffic accidents, falls, other), and CXR and CT results. Additionally, the intervention types (thoracostomy tube insertion, thoracentesis, no intervention) during the early phase of the management were recorded. All chest x-rays were performed on the supine position based on the trauma protocol of the hospital. Cases missed by the CXR but identified in the CT were defined as OPTX. Using the web-based Java applet developed by Russ Lenth (https://homepage.divms.uiowa.edu/~rlenth/Power/), a post hoc sample size calculation was performed based on a 7% expected prevalence of OPTX. Given an infinite population and a margin of error of 5%, a sample size of 100 cases is required to estimate OPTX in the study population with a confidence interval of 95%. Statistical analysis was performed with the Statistical Package for the Social Sciences version 22 (SPSS, IBM, Armonk, NY, USA). The 'number (n),' 'percentage (%),' 'mean,' and 'standard deviation (SD)' was given for the descriptive statistics. Pearson Chi-Square or Fisher's exact tests used to compare categorical data. Age between groups was analyzed using the Mann-Whitney U test. Logistic regression analysis was applied to check for independent factors affecting the presence of OPTX. The results were evaluated with a confidence interval of 95%, and the level of significance, p, was set at <0.05.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occult pneumothorax in trauma patients | – | Other: Evaluation of occult pneumothorax in who had a blunt or penetrating chest traumaAge>16, multi-trauma, consulted thoracic surgeon, underwent CXR- CT. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive participants over the age of 16 who were admitted to the ED between the 1st of January 2008 and 31st of December 2010 due to multi-trauma, consulted by a thoracic surgeon and underwent both CXR and CT were included in the study.
Key inclusion criteria (1 listed)
- >16 years of age consulted by a thoracic surgeon had a multi-trauma underwent both chest x ray and computed tomography
Key exclusion criteria (1 listed)
- <16 years of age not consulted by a thoracic surgeon did not have a multi-trauma did not undergo both chest x ray and computed tomography
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 |
|---|---|---|
| Evaluation of occult pneumothorax in who had a blunt or penetrating chest traumaAlso: Trauma, Pneumothorax | Other | Occult pneumothorax in trauma patients |
Primary outcome
Occult Pneumothorax in Patients with Blunt or Penetrating Thoracic Trauma
Time frame: Through study completion, an average of 1 year
Patient Registry
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 Dec 2019.
- Results publication: PubMed 19539280Wilson H, Ellsmere J, Tallon J, Kirkpatrick A. Occult pneumothorax in the blunt trauma patient: tube thoracostomy or observation? Injury. 2009 Sep;40(9):928-31. doi: 10.1016/j.injury.2009.04.005. Epub 2009 Jun 17.
- Results publication: PubMed 17925411Soldati G, Testa A, Sher S, Pignataro G, La Sala M, Silveri NG. Occult traumatic pneumothorax: diagnostic accuracy of lung ultrasonography in the emergency department. Chest. 2008 Jan;133(1):204-11. doi: 10.1378/chest.07-1595. Epub 2007 Oct 9.
- Results publication: PubMed 29766125Kunitake RC, Kornblith LZ, Cohen MJ, Callcut RA. Trauma Early Mortality Prediction Tool (TEMPT) for assessing 28-day mortality. Trauma Surg Acute Care Open. 2018 Jan 8;3(1):e000131. doi: 10.1136/tsaco-2017-000131. eCollection 2018.
- Results publication: PubMed 21546439Ding W, Shen Y, Yang J, He X, Zhang M. Diagnosis of pneumothorax by radiography and ultrasonography: a meta-analysis. Chest. 2011 Oct;140(4):859-866. doi: 10.1378/chest.10-2946. Epub 2011 May 5.
- Results publication: PubMed 15862493Ball CG, Kirkpatrick AW, Laupland KB, Fox DL, Litvinchuk S, Dyer DM, Anderson IB, Hameed SM, Kortbeek JB, Mulloy R. Factors related to the failure of radiographic recognition of occult posttraumatic pneumothoraces. Am J Surg. 2005 May;189(5):541-6; discussion 546. doi: 10.1016/j.amjsurg.2005.01.018.
- Results publication: PubMed 29849996Chan YH, Zeng YZ, Wu HC, Wu MC, Sun HM. Effective Pneumothorax Detection for Chest X-Ray Images Using Local Binary Pattern and Support Vector Machine. J Healthc Eng. 2018 Apr 3;2018:2908517. doi: 10.1155/2018/2908517. eCollection 2018.
- Results publication: PubMed 11265032Holmes JF, Brant WE, Bogren HG, London KL, Kuppermann N. Prevalence and importance of pneumothoraces visualized on abdominal computed tomographic scan in children with blunt trauma. J Trauma. 2001 Mar;50(3):516-20. doi: 10.1097/00005373-200103000-00017.
- Results publication: PubMed 24730407Lee LK, Rogers AJ, Ehrlich PF, Kwok M, Sokolove PE, Blumberg S, Kooistra J, Olsen CS, Wootton-Gorges S, Cooper A, Kuppermann N, Holmes JF; Pediatric Emergency Care Applied Research Network (PECARN). Occult pneumothoraces in children with blunt torso trauma. Acad Emerg Med. 2014 Apr;21(4):440-8. doi: 10.1111/acem.12344.
- Results publication: PubMed 22835995Akoglu H, Akoglu EU, Evman S, Akoglu T, Denizbasi A, Guneysel O, Onur O, Onur E. Utility of cervical spinal and abdominal computed tomography in diagnosing occult pneumothorax in patients with blunt trauma: Computed tomographic imaging protocol matters. J Trauma Acute Care Surg. 2012 Oct;73(4):874-9. doi: 10.1097/TA.0b013e3182569ff2.
- Results publication: PubMed 17414339Plurad D, Green D, Demetriades D, Rhee P. The increasing use of chest computed tomography for trauma: is it being overutilized? J Trauma. 2007 Mar;62(3):631-5. doi: 10.1097/TA.0b013e31802bf009.
- Results publication: PubMed 8230337Enderson BL, Abdalla R, Frame SB, Casey MT, Gould H, Maull KI. Tube thoracostomy for occult pneumothorax: a prospective randomized study of its use. J Trauma. 1993 Nov;35(5):726-9; discussion 729-30.
- Results publication: PubMed 19306978Ouellet JF, Trottier V, Kmet L, Rizoli S, Laupland K, Ball CG, Sirois M, Kirkpatrick AW. The OPTICC trial: a multi-institutional study of occult pneumothoraces in critical care. Am J Surg. 2009 May;197(5):581-6. doi: 10.1016/j.amjsurg.2008.12.007.
- Individual participant dataSharing planned: Yes. All collected individual participating data
Related trials for Pneumothorax; Acute
Recruiting
Clinical Utility of Portable Dynamic Chest X Ray (DDR) in the ICU
Pulmonary Edema, Pneumonia
Recruiting
Intraoperative Paravertebral Block and Postoperative Complications
Video-assisted Thoracoscopic Surgery (VATS), Lung Cancer (Diagnosis)
RecruitingObservational study
Laboratory Biomarkers and Pulmonary Interstitial Emphysema in ARDS (PIE-ARDS)
Acute Respiratory Distress Syndrome, Barotrauma
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.
Semra Aslay, M.D. study director
European University of Lefke
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax; Acute and Trauma Chest, run by European University of Lefke.
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: finished, as of the sponsor's last update on 6 Dec 2019. 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?
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?
Occult Pneumothorax in Patients with Blunt or Penetrating Thoracic Trauma (time frame: Through study completion, an average of 1 year). 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 NCT04188938, which also lists 27 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 6 Dec 2019.