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PneumothoraxNCT02907866

Use of Endobronchial Ultrasound Scope (EBUS) Transducer to Identify Pneumothorax-A Feasibility Study

An observational study of Pneumothorax, run by University of Oklahoma at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Endobronchial ultrasound (EBUS) is a technique that uses ultrasound along with bronchoscope to visualize airway wall and structures adjacent to it. Pneumothorax is a known complication from EBUS procedure. To rule out a Pneumothorax after the procedure, a Chest -X-ray is usually done. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumothorax
What is being tested?
Ultrasound with EBUS scope and with linear ultrasound probe
Type of treatment
Medical device
How many people
17 participants
Where
1 siteUnited States
Study dates
Sep 2016to 9 Feb 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 1. All patients presenting for bronchoscopy (These patient are expected to have normal pleural sliding sign identified by ultrasound) 2. Patients with pneumothorax requiring chest tube(This group of patient is expected to have residual pneumothorax for identification of absence of lung sliding, B lines and lung point) 3. Patients with respiratory failure on mechanical ventilation(This group of patient is expected to have alveolo-interstitial findings such as B lines)

Who may be able to join

  • All patients presenting for bronchoscopy (These patient are expected to have normal pleural sliding sign identified by ultrasound)
  • Patients with pneumothorax requiring chest tube(This group of patient is expected to have residual pneumothorax for identification of absence of lung sliding, B lines and lung point)
  • Patients with respiratory failure on mechanical ventilation(This group of patient is expected to have alveolo-interstitial findings such as B lines)

Who cannot join

  • -Absence of informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oklahoma University Medical center

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Endobronchial ultrasound (EBUS) is a technique that uses ultrasound along with bronchoscope to visualize airway wall and structures adjacent to it. Pneumothorax is a known complication from EBUS procedure. To rule out a Pneumothorax after the procedure, a Chest -X-ray is usually done. Point-of-care sonography has emerged as an invaluable tool in the assessment of patients with both traumatic and non-traumatic dyspnea. Multiple studies involving bedside ultrasound has shown that a pneumothorax can easily be ruled out if pleural sliding sign or B lines are visualized on lung ultrasonography; the accuracy of lung ultrasound in ruling out pneumothorax approach computed tomography and exceed plain radiography. Preforming a lung ultrasound using the EBUS bronchoscope tip as a way to rule out pneumothorax has never been described previously. If this is possible it will obviate the need of getting a Chest -X-ray and decrease the dose of radiation that the patient is exposed to. In this study we will demonstrate that the feasibility of using the transducer of the EBUS Bronchoscope to perform bedside lung ultrasound to rule out pneumothorax.

Read the detailed description

The use of ultrasound in diagnosis and treatment of patients has been well-established for many decades. The use of thoracic ultrasonography is a fairly new and rapidly evolving field. The interface between the ultrasound probe and chest wall can produce artifacts that can be useful in diagnosing a pneumothorax. In one prospective study the utility of ultrasound was compared to chest X-ray and CT-scan by trauma surgeon (1). Their results demonstrate that ultrasound was more sensitive than chest X-ray to identify early pneumothorax. The study also demonstrated that 63% of pneumothoraxes diagnosed were occult and would have been later diagnosed on CT chest. In these critical situations where is subtle pneumothorax can be missed, a bedside ultrasound has been proven to accelerate the diagnosis and thus treatment. Similarly another prospective study noted that up to 76% of all traumatic pneumothoraxes were missed by standard AP chest X-ray, when interpreted by trauma team (2). This number was significantly higher than a retrospective study in which 55% of pneumothoraxes were missed on AP chest films reviewed by radiologist (3). The sensitivity of ultrasound in detecting pneumothorax has been demonstrated in multiple studies to be similar to CT-scan, which is considered to be gold standard for the detection of pneumothorax (4, 5).

Visualization of normal pleural lung sliding is itself sufficient to exclude pneumothorax , if lung sliding is not present the finding of B lines( vertical lines), which usually originate from the lung parenchyma will also exclude the possibility of pneumothorax at the interspace in question, since the lung parenchyma cannot be visualized if there is air interposed between the pleura and the lung.

Endobronchial ultrasound (EBUS) is considered an integral component of diagnosis of indeterminate mediastinal lymph nodes, masses and peripheral pulmonary nodules. EBUS is minimally invasive, safe and highly accurate (6). According to current estimates that incidence if complications associated with EBUS is between 1-1.5% (6, 7). Major complications are associated with needle aspirations. The incidence of pneumothorax was found to be 3.3% in one retrospective analysis (8), with 31% of patients requiring chest tube eventually for treatment of pneumothorax. Post-procedure chest-X-rays are commonly performed to rule out pneumothorax. Based on current data chest-X-rays are considered suboptimal for diagnosis of pneumothorax and can also expose patients to undue radiation.

The EBUS probe contains a small ultrasound through which ultrasound images of various structure i.e. lymph nodes, ventricles, pulmonary vasculature can be visualized. Ruling out pneumothorax via lung ultrasound using EBUS probe has never been described. If this is possible, it avoids the need of obtaining post-procedure Chest-X-rays thus decreasing the dose of radiation exposure and prevent time delays for the arrival of chest-x-rays.

In this study we will demonstrate the feasibility of using the transducer of the EBUS Bronchoscope to perform bedside lung ultrasound to rule out pneumothorax.

Conditions
Pneumothorax
Being tested
Ultrasound with EBUS scope and with linear ultrasound probe
Medical subject headings
Pneumothorax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound with EBUS scope and with linear ultrasound probeDevice

    All subjects will have an ultrasound of the chest performed with the tip of the EBUS scope as well as the linear ultrasound probe, which will be used as a reference for comparison. At the end of the procedure, while the patient in the supine position, the transducer of the EBUS bronchoscope will be placed on the anterior thorax, superficial to the skin and in a sagittal direction that is perpendicular to 2 ribs. The depth of the ultrasound beam will be increased to identify the pleural sliding sign and B lines (vertical lines) when present.This will be followed by use of linear ultrasound probe to scan the chest wall for normal lung sliding, B-lines and potential pneumothorax. The patient will remain in supine position. The linear probe will be placed on anterior thorax at the level of second intercostal space. The depth of the ultrasound beam will be adjusted to identify lung sliding and B-lines.

Study groups in NCT02907866
Study groupRoleWhat they receive
Patients undergoing bronchoscopyAll patients presenting for bronchoscopy (These patient are expected to have normal pleural sliding sign identified by ultrasound)
Receives: Device: Ultrasound with EBUS scope and with linear ultrasound probe
Patients with pneumothoraxPatients with pneumothorax requiring chest tube(This group of patient is expected to have residual pneumothorax for identification of absence of lung sliding, B lines and lung point)
Receives: Device: Ultrasound with EBUS scope and with linear ultrasound probe
Patients on mechanical ventilationPatients with respiratory failure on mechanical ventilation(This group of patient is expected to have alveolo-interstitial findings such as B lines)
Receives: Device: Ultrasound with EBUS scope and with linear ultrasound probe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage of patients on whom a sliding sign and/or B lines are identified successfully with EBUS versus linear US

    Measured: 1 Hour

Secondary outcomes (2)
  1. Sensitivity, specificity, negative and positive predictive value of the bedside lung ultrasound using the EBUS transducer to detect pneumothorax as compared to the linear US, the bedside Chest X-ray and the final clinical diagnosis of pneumothorax.

    Measured: 1 Hour

  2. The Time elapsed between the end of the bronchoscopy and the completion of lung ultrasound will be compared to the time between the end of the bronchoscopy and the availability of CXR imaging.

    Measured: 1 Hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion9 Feb 2024
  4. Study completion9 Feb 2024

Why it stopped: Study was administratively inactivated by the IRB due to no response to Continuing Review requirement.

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
Cross-sectional
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907866
Sponsor's protocol ID
6622
Status last verified
Mar 2026
First submitted
14 Sep 2016
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Kirkpatrick AW, Sirois M, Laupland KB, Liu D, Rowan K, Ball CG, Hameed SM, Brown R, Simons R, Dulchavsky SA, Hamiilton DR, Nicolaou S. Hand-held thoracic sonography for detecting post-traumatic pneumothoraces: the Extended Focused Assessment with Sonography for Trauma (EFAST). J Trauma. 2004 Aug;57(2):288-95. doi: 10.1097/01.ta.0000133565.88871.e4.

    PubMed 15345974
  • Ball CG, Ranson K, Dente CJ, Feliciano DV, Laupland KB, Dyer D, Inaba K, Trottier V, Datta I, Kirkpatrick AW. Clinical predictors of occult pneumothoraces in severely injured blunt polytrauma patients: A prospective observational study. Injury. 2009 Jan;40(1):44-7. doi: 10.1016/j.injury.2008.07.015. Epub 2009 Jan 8.

    PubMed 19131061
  • Ball CG, Kirkpatrick AW, Laupland KB, Fox DI, Nicolaou S, Anderson IB, Hameed SM, Kortbeek JB, Mulloy RR, Litvinchuk S, Boulanger BR. Incidence, risk factors, and outcomes for occult pneumothoraces in victims of major trauma. J Trauma. 2005 Oct;59(4):917-24; discussion 924-5. doi: 10.1097/01.ta.0000174663.46453.86.

    PubMed 16374282
  • Blaivas M, Lyon M, Duggal S. A prospective comparison of supine chest radiography and bedside ultrasound for the diagnosis of traumatic pneumothorax. Acad Emerg Med. 2005 Sep;12(9):844-9. doi: 10.1197/j.aem.2005.05.005.

    PubMed 16141018
  • 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
  • Asano F, Aoe M, Ohsaki Y, Okada Y, Sasada S, Sato S, Suzuki E, Semba H, Fukuoka K, Fujino S, Ohmori K. Complications associated with endobronchial ultrasound-guided transbronchial needle aspiration: a nationwide survey by the Japan Society for Respiratory Endoscopy. Respir Res. 2013 May 10;14(1):50. doi: 10.1186/1465-9921-14-50.

    PubMed 23663438
  • Eapen GA, Shah AM, Lei X, Jimenez CA, Morice RC, Yarmus L, Filner J, Ray C, Michaud G, Greenhill SR, Sarkiss M, Casal R, Rice D, Ost DE; American College of Chest Physicians Quality Improvement Registry, Education, and Evaluation (AQuIRE) Participants. Complications, consequences, and practice patterns of endobronchial ultrasound-guided transbronchial needle aspiration: Results of the AQuIRE registry. Chest. 2013 Apr;143(4):1044-1053. doi: 10.1378/chest.12-0350.

    PubMed 23117878
  • Huang CT, Ruan SY, Liao WY, Kuo YW, Lin CY, Tsai YJ, Ho CC, Yu CJ. Risk factors of pneumothorax after endobronchial ultrasound-guided transbronchial biopsy for peripheral lung lesions. PLoS One. 2012;7(11):e49125. doi: 10.1371/journal.pone.0049125. Epub 2012 Nov 7.

    PubMed 23145094

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumothorax, run by University of Oklahoma at 1 site in United States.

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 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: stopped early, as of the sponsor's last update on 1 Apr 2026. 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 United States. 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 was stopped early (reason given: Study was administratively inactivated by the IRB due to no response to Continuing Review requirement.). Results are not available in the source record.

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?

The percentage of patients on whom a sliding sign and/or B lines are identified successfully with EBUS versus linear US (time frame: 1 Hour). 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 NCT02907866, which also lists 8 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 1 Apr 2026.

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