Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax (LUSvsCXR)

December 17, 2025 updated by: Jacobo Moreno Garijo, Sunnybrook Health Sciences Centre

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Science Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Diagnostic modalities comparison
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 12 months (full pilot trial)
The total number of participants recruited during the pilot trial. Target: 60 participants.
12 months (full pilot trial)
Adherence to LUS Scan Protocol
Time Frame: 12 months (full pilot trial)
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
Time Frame: 12 months (full pilot trial)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare novice-performed LUS with CXR reports performed by experienced radiologists.
Time Frame: 12 months (full pilot trial)
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)
Diagnostic accuracy of LUS vs CXR
Time Frame: 12 months (full pilot trial)
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)
Diagnostic Sensitivity of CXR vs LUS
Time Frame: 12 months (full pilot trial)
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)
Interrater reliability
Time Frame: 12 months (full pilot trial)
Assess the interrater reliability of novice and expert sonographers.
12 months (full pilot trial)
Time Required
Time Frame: 12 months (full pilot trial)
Assess the time required from chest/mediastinal tube removal to diagnostic report for LUS vs CXR.
12 months (full pilot trial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Jacobo Moreno Garijo, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2023

Primary Completion (Actual)

July 23, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 16, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5854

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be available upon request

IPD Sharing Time Frame

Upon publication, no limit on time

IPD Sharing Access Criteria

Contact study investigators

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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