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

Primary Purpose

Pneumothorax

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lung ultrasound to detect pneumothorax.
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumothorax focused on measuring Pneumothorax, Lung Ultrasound, Chest X-Ray, Trauma patients, Cardiac Surgery, Chest Drain Removal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sunnybrook Health Science Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Diagnostic modalities comparison

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).
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).
Interrater reliability
Assess the interrater reliability of novice and expert sonographers.
Time Required
Assess the time required from chest/mediastinal tube removal to diagnostic report for LUS vs CXR.

Full Information

First Posted
August 16, 2023
Last Updated
August 30, 2023
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT06022081
Brief Title
Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
Keywords
Pneumothorax, Lung Ultrasound, Chest X-Ray, Trauma patients, Cardiac Surgery, Chest Drain Removal

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic modalities comparison
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung ultrasound to detect pneumothorax.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
The total number of participants recruited during the pilot trial. Target: 60 participants.
Time Frame
12 months (full pilot trial)
Title
Adherence to LUS Scan Protocol
Description
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.
Time Frame
12 months (full pilot trial)
Title
Feasibility of Accurate LUS Data Collection for Comparison with Chest X-rays
Description
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.
Time Frame
12 months (full pilot trial)
Secondary Outcome Measure Information:
Title
Compare novice-performed LUS with CXR reports performed by experienced radiologists.
Description
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.
Time Frame
12 months (full pilot trial)
Title
Diagnostic accuracy of LUS vs CXR
Description
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).
Time Frame
12 months (full pilot trial)
Title
Diagnostic Sensitivity of CXR vs LUS
Description
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).
Time Frame
12 months (full pilot trial)
Title
Interrater reliability
Description
Assess the interrater reliability of novice and expert sonographers.
Time Frame
12 months (full pilot trial)
Title
Time Required
Description
Assess the time required from chest/mediastinal tube removal to diagnostic report for LUS vs CXR.
Time Frame
12 months (full pilot trial)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacobo Moreno Garijo, MD
Phone
416-480-4864
Email
jacobo.morenogarijo@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lilia Kaustov, PhD
Phone
416-480-6100
Ext
89607
Email
lilia.kaustov@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacobo Moreno Garijo, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacobo Moreno Garijo, MD
Phone
416-480-4864
Email
jacobo.morenogarijo@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Lilia Kaustov
Phone
416-480-6100
Ext
89607
Email
lilia.kaustov@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Jacobo Moreno Garijo, MD
First Name & Middle Initial & Last Name & Degree
Angela Jerath, MD
First Name & Middle Initial & Last Name & Degree
Colin McCartney, MD
First Name & Middle Initial & Last Name & Degree
Barbara Haas, MD
First Name & Middle Initial & Last Name & Degree
Stephen Fremes, MD
First Name & Middle Initial & Last Name & Degree
Gideon Cohen, MD
First Name & Middle Initial & Last Name & Degree
Idan Roifman, MD
First Name & Middle Initial & Last Name & Degree
Dennis Ko, MD
First Name & Middle Initial & Last Name & Degree
Beth Linseman, RN
First Name & Middle Initial & Last Name & Degree
Heather Harrington, RN
First Name & Middle Initial & Last Name & Degree
Alexander Kiss, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
18539477
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.
Results Reference
background
PubMed Identifier
11303163
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.
Results Reference
background
PubMed Identifier
12643411
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.
Results Reference
background
PubMed Identifier
11819085
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.
Results Reference
background
PubMed Identifier
20113700
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.
Results Reference
background
PubMed Identifier
21701019
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.
Results Reference
background
PubMed Identifier
32313780
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.
Results Reference
background
PubMed Identifier
3872573
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.
Results Reference
background
PubMed Identifier
20382717
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.
Results Reference
background
PubMed Identifier
19865549
Citation
Ball CG, Kirkpatrick AW, Feliciano DV. The occult pneumothorax: what have we learned? Can J Surg. 2009 Oct;52(5):E173-9.
Results Reference
background

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Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax

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