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

NCT02907866 | Terminated DMC

• 1 other identifier: 6622
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pneumothorax

Outcome Measures

Primary Outcomes (1)

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

  1 Hour

Secondary Outcomes (2)

• 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.

  1 Hour

• 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.

  1 Hour

Study Arms (3)

Patients undergoing bronchoscopy

All patients presenting for bronchoscopy (These patient are expected to have normal pleural sliding sign identified by ultrasound)

Device: Ultrasound with EBUS scope and with linear ultrasound probe

Patients with pneumothorax

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)

Device: Ultrasound with EBUS scope and with linear ultrasound probe

Patients on mechanical ventilation

Patients with respiratory failure on mechanical ventilation(This group of patient is expected to have alveolo-interstitial findings such as B lines)

Device: Ultrasound with EBUS scope and with linear ultrasound probe

Interventions

Ultrasound with EBUS scope and with linear ultrasound probe DEVICE

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.

Patients on mechanical ventilation; Patients undergoing bronchoscopy; Patients with pneumothorax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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)

You may not qualify if:

• Absence of informed consent

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Oklahoma University Medical center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (8)

• 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.

  PMID: 15345974 BACKGROUND

• 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.

  PMID: 19131061 BACKGROUND

• 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.

  PMID: 16374282 BACKGROUND

• 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.

  PMID: 16141018 BACKGROUND

• 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.

  PMID: 17925411 BACKGROUND

• 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.

  PMID: 23663438 BACKGROUND

• 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.

  PMID: 23117878 BACKGROUND

• 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.

  PMID: 23145094 BACKGROUND

MeSH Terms

Conditions

Pneumothorax

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2016
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)