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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT04188938
Study groupRoleWhat they receive
Occult pneumothorax in trauma patientsAge>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.

  1. 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.

  1. First posted6 Dec 2019
  2. Study start1 Jan 2008
  3. Primary completion31 Dec 2010
  4. Study completion19 Apr 2011

Resources

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
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 19539280
  • Soldati 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 17925411
  • Kunitake 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 29766125
  • Ding 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 21546439
  • Ball 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 15862493
  • Chan 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 29849996
  • Holmes 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 11265032
  • Lee 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 24730407
  • Akoglu 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 22835995
  • Plurad 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 17414339
  • Enderson 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 8230337
  • Ouellet 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 19306978
  • Ball CG, Kirkpatrick AW, Feliciano DV. The occult pneumothorax: what have we learned? Can J Surg. 2009 Oct;52(5):E173-9.

    PubMed 19865549
  • Matsumoto 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 20864214
  • Ball 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

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.

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