Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax

NCT06022081 | Active Not Recruiting

• 1 other identifier: 5854
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumothorax

Keywords

Pneumothorax; Lung Ultrasound; Chest X-Ray; Trauma patients; Cardiac Surgery; Chest Drain Removal

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  The total number of participants recruited during the pilot trial. Target: 60 participants.

  12 months (full pilot trial)

• 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)

• 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 Outcomes (5)

• Compare novice-performed LUS with CXR reports performed by experienced radiologists.

  12 months (full pilot trial)

• Diagnostic accuracy of LUS vs CXR

  12 months (full pilot trial)

• Diagnostic Sensitivity of CXR vs LUS

  12 months (full pilot trial)

• Interrater reliability

  12 months (full pilot trial)

• Time Required

  12 months (full pilot trial)

Study Arms (1)

Diagnostic modalities comparison

OTHER

All participants belong to a single arm. A chest X-ray (CXR) and lung ultrasound (LUS) in a predetermined order (CXR followed by LUS), will be performed sequentially for pneumothorax (PNX) detection after chest/mediastinal tube removal. There is no control group or randomization.

Diagnostic Test: Lung ultrasound to detect pneumothorax.

Interventions

Lung ultrasound to detect pneumothorax. DIAGNOSTIC_TEST

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.

Diagnostic modalities comparison

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (10)

• 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.

  PMID: 18539477 BACKGROUND

• 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.

  PMID: 11303163 BACKGROUND

• 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.

  PMID: 12643411 BACKGROUND

• 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.

  PMID: 11819085 BACKGROUND

• 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.

  PMID: 20113700 BACKGROUND

• 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.

  PMID: 21701019 BACKGROUND

• 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.

  PMID: 32313780 BACKGROUND

• 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.

  PMID: 3872573 BACKGROUND

• 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.

  PMID: 20382717 BACKGROUND

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

  PMID: 19865549 BACKGROUND

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Jacobo Moreno Garijo, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Model Details: Single-group study where the focus is on evaluating the diagnostic accuracy of both CXR and LUS for PNX detection post-tube removal in cardiac surgery and trauma patients. The study aims to compare the results of both modalities within the same group of participants to assess their performance in detecting PNX.

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: September 1, 2023
• Study Start: September 27, 2023
• Primary Completion: July 23, 2024
• Study Completion: December 1, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon publication, no limit on time
• Access Criteria: Contact study investigators

Locations

CA (1)