Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax

Pneumothorax Clinical Trial

— LUSvsCXR  

Official title:

Comparative Evaluation of Novice-Performed Lung Ultrasound vs. Chest X-Ray for Pneumothorax Detection Post-Chest Tube Removal in Cardiac Surgery and Trauma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06022081
• Other study ID #: 5854
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Jacobo Moreno Garijo, MD
• Phone: 416-480-4864
• Email: jacobo.morenogarijo[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sunnybrook Health Sciences Center annually provides assistance to approximately 600 cardiac surgeries and 1500 trauma patients, many of whom require chest tubes to prevent blood and fluids from accumulating in the pleural cavities surrounding the heart. During the removal of chest tubes, there is a risk of air leaking into these cavities, leading to pneumothorax, a critical condition occurring in approximately 5-26% of cases, associated with increased complications and mortality. Currently, the diagnosis of pneumothorax is primarily based on chest X-rays (CXR), despite their limitations and low reliability. As an alternative method, lung ultrasound (LUS) offers several advantages: it is safer, less expensive, and less painful for patients compared to CXR. However, there is a lack of comparative data on the accuracy and interrater reliability of these two diagnostic approaches after chest tube removal. This study aims to evaluate the accuracy of lung ultrasound performed by medical trainees in diagnosing pneumothorax in cardiac and trauma patients. By comparing LUS to CXR, the investigators seek to determine if LUS provides a more reliable and precise diagnosis. This study has the potential to enhance patient care by establishing a more effective and accessible method for diagnosing pneumothorax post-chest tube removal.

Description:

Diagnosing and promptly treating pneumothorax (PNX) is critical, as it is associated with increased morbidity, mortality, and hospital stay for patients. Following cardiac surgery, timely identification of PNX is particularly vital due to patients' reduced cardiopulmonary reserve, which can rapidly lead to life-threatening situations. While computed tomography (CT) is highly accurate in diagnosing PNX, its routine use for screening is impractical due to high radiation exposure, cost, and limited availability. Currently, the standard method for PNX detection is chest X-ray (CXR), but its reliability is suboptimal, resulting in potential misdiagnoses and delays in patient care. An alternate method for detecting PNX is using lung ultrasound (LUS). LUS is safe, portable compared to CXR, has the potential for faster results and higher accuracy relative to CXR. LUS can also be carried out by appropriate trained nurses and medical trainees, instead of requiring an expert radiographer. This prospective, single-center, observational, cross-sectional, cohort, feasibility pilot trial assesses trainee-performed bedside lung ultrasound (LUS) for detecting PNX and testing feasibility for a multicenter observational prospective study. The investigators will also compare PNX detection using LUS by novices compared to experts, interrater reliability and the time required from chest/mediastinal tube removal to diagnostic report for LUS. All participants will undergo assessment for PNX using both LUS and CXR completed independently (by study-trained critical care nurse/surgical trainee or an expert radiologist, respectively) and results will be compared between the two modalities. The successful implementation of LUS could lead to streamlined patient care and improved outcomes for cardiac surgery and trauma patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old.
• Cardiac and trauma patients who have had a chest/mediastinal tube removed within the past two hours in the CVICU, trauma bay, or ward.

Exclusion Criteria:

• Patients who had a PNX prior to mediastinal chest tube removal that required intervention.
• Patients on mechanical ventilation.
• Patients with subcutaneous emphysema due to impaired pleural line visualization.

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Diagnostic Test:
• Lung ultrasound to detect pneumothorax.
Within a maximum of two hours after chest tube removal, the sonographic exam will be performed with an ultrasound device to assess residual PNX using a portable ultrasound device. The examination will require patients to lie face upward and will be performed at three different sites on both sides of the patient's chest. Each chest site will be imaged for approximately 10-20 seconds, allowing a complete examination of each side in approximately 30-60 seconds. The total study time for the LUS exam is approximately 2 minutes. The results of this assessment will be compared to the standard chest x-ray performed by a radiologist who is unaware of the study.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Science Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (10)

Ball CG, Kirkpatrick AW, Feliciano DV. The occult pneumothorax: what have we learned? Can J Surg. 2009 Oct;52(5):E173-9. — View Citation

Bell RL, Ovadia P, Abdullah F, Spector S, Rabinovici R. Chest tube removal: end-inspiration or end-expiration? J Trauma. 2001 Apr;50(4):674-7. doi: 10.1097/00005373-200104000-00013. — View Citation

Diaz R, Patel KB, Almeida P, Shekar SP, Hernandez F, Mehta JP. Are Chest Radiographs Routinely Indicated After Chest Tubes Placed for Non-Surgical Reasons Are Removed? Cureus. 2020 Mar 20;12(3):e7339. doi: 10.7759/cureus.7339. — View Citation

Eisenberg RL, Khabbaz KR. Are chest radiographs routinely indicated after chest tube removal following cardiac surgery? AJR Am J Roentgenol. 2011 Jul;197(1):122-4. doi: 10.2214/AJR.10.5856. — View Citation

Galbois A, Ait-Oufella H, Baudel JL, Kofman T, Bottero J, Viennot S, Rabate C, Jabbouri S, Bouzeman A, Guidet B, Offenstadt G, Maury E. Pleural ultrasound compared with chest radiographic detection of pneumothorax resolution after drainage. Chest. 2010 Sep;138(3):648-55. doi: 10.1378/chest.09-2224. Epub 2010 Apr 9. — View Citation

Goodman MD, Huber NL, Johannigman JA, Pritts TA. Omission of routine chest x-ray after chest tube removal is safe in selected trauma patients. Am J Surg. 2010 Feb;199(2):199-203. doi: 10.1016/j.amjsurg.2009.03.011. — View Citation

Khan T, Chawla G, Daniel R, Swamy M, Dimitri WR. Is routine chest X-ray following mediastinal drain removal after cardiac surgery useful? Eur J Cardiothorac Surg. 2008 Sep;34(3):542-4. doi: 10.1016/j.ejcts.2008.05.002. Epub 2008 Jun 9. — View Citation

McCormick JT, O'Mara MS, Papasavas PK, Caushaj PF. The use of routine chest X-ray films after chest tube removal in postoperative cardiac patients. Ann Thorac Surg. 2002 Dec;74(6):2161-4. doi: 10.1016/s0003-4975(02)03982-6. — View Citation

Pacharn P, Heller DN, Kammen BF, Bryce TJ, Reddy MV, Bailey RA, Brasch RC. Are chest radiographs routinely necessary following thoracostomy tube removal? Pediatr Radiol. 2002 Feb;32(2):138-42. doi: 10.1007/s00247-001-0591-5. Epub 2001 Nov 24. — View Citation

Tocino IM, Miller MH, Fairfax WR. Distribution of pneumothorax in the supine and semirecumbent critically ill adult. AJR Am J Roentgenol. 1985 May;144(5):901-5. doi: 10.2214/ajr.144.5.901. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	The total number of participants recruited during the pilot trial. Target: 60 participants.	12 months (full pilot trial)
Primary	Adherence to LUS Scan Protocol	The proportion of participants who receive the LUS scans as per the trial protocol. This will be assessed by checking the frequency of LUS scans conducted for each participant against the planned frequency in the protocol. Measurement Tool: Frequency count of LUS scans against planned protocol scans.	12 months (full pilot trial)
Primary	Feasibility of Accurate LUS Data Collection for Comparison with Chest X-rays	Evaluate the feasibility of obtaining accurate LUS data suitable for comparison against Chest X-rays. The accuracy of LUS scans will be determined by the clarity and consistency of recorded data points. For the purpose of this study, 'accuracy' will be defined by a set of criteria based on sonographic signs of pneumothorax that include: absence of lung sliding, absence of B lines, presence of lung point, and absence of lung pulse. The primary outcome will be the proportion of LUS scans that meet this accuracy threshold. Measurement Tool: Qualitative assessment criteria tailored for this study. LUS scans will be evaluated based on clarity, consistency of recorded data points, and adherence to the sonographic signs of pneumothorax as listed above. The results from LUS will then be prepared for comparison against Chest X-ray findings in subsequent analyses.	12 months (full pilot trial)
Secondary	Compare novice-performed LUS with CXR reports performed by experienced radiologists.	The results of the assessments will be analyzed to determine the sensitivity, specificity, positive predictive value, and negative predictive value of pneumothorax detection by novices compared to experts.	12 months (full pilot trial)
Secondary	Diagnostic accuracy of LUS vs CXR	Assess diagnostic accuracy and sensitivity of PNX detection by CXR and LUS (80% interrater reliability with the results when LUS is adjudicated by an expert for detecting PNX post-chest/mediastinal tube removal).	12 months (full pilot trial)
Secondary	Diagnostic Sensitivity of CXR vs LUS	Assess diagnostic sensitivity of PNX detection by CXR and LUS (80% interrater reliability with the results when LUS is adjudicated by an expert for detecting PNX post-chest/mediastinal tube removal).	12 months (full pilot trial)
Secondary	Interrater reliability	Assess the interrater reliability of novice and expert sonographers.	12 months (full pilot trial)
Secondary	Time Required	Assess the time required from chest/mediastinal tube removal to diagnostic report for LUS vs CXR.	12 months (full pilot trial)