xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06022081</url>
    </required_header>
    <id_info>
      <org_study_id>5854</org_study_id>
      <nct_id>NCT06022081</nct_id>
    </id_info>
    <brief_title>Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax</brief_title>
    <acronym>LUSvsCXR</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sunnybrook Health Sciences Centre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sunnybrook Health Sciences Centre</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Sunnybrook Health Sciences Center annually provides assistance to approximately 600 cardiac&#xD;
        surgeries and 1500 trauma patients, many of whom require chest tubes to prevent blood and&#xD;
        fluids from accumulating in the pleural cavities surrounding the heart. During the removal of&#xD;
        chest tubes, there is a risk of air leaking into these cavities, leading to pneumothorax, a&#xD;
        critical condition occurring in approximately 5-26% of cases, associated with increased&#xD;
        complications and mortality.&#xD;
  &#xD;
        Currently, the diagnosis of pneumothorax is primarily based on chest X-rays (CXR), despite&#xD;
        their limitations and low reliability. As an alternative method, lung ultrasound (LUS) offers&#xD;
        several advantages: it is safer, less expensive, and less painful for patients compared to&#xD;
        CXR. However, there is a lack of comparative data on the accuracy and interrater reliability&#xD;
        of these two diagnostic approaches after chest tube removal.&#xD;
  &#xD;
        This study aims to evaluate the accuracy of lung ultrasound performed by medical trainees in&#xD;
        diagnosing pneumothorax in cardiac and trauma patients. By comparing LUS to CXR, the&#xD;
        investigators seek to determine if LUS provides a more reliable and precise diagnosis. This&#xD;
        study has the potential to enhance patient care by establishing a more effective and&#xD;
        accessible method for diagnosing pneumothorax post-chest tube removal.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Diagnosing and promptly treating pneumothorax (PNX) is critical, as it is associated with&#xD;
        increased morbidity, mortality, and hospital stay for patients. Following cardiac surgery,&#xD;
        timely identification of PNX is particularly vital due to patients' reduced cardiopulmonary&#xD;
        reserve, which can rapidly lead to life-threatening situations. While computed tomography&#xD;
        (CT) is highly accurate in diagnosing PNX, its routine use for screening is impractical due&#xD;
        to high radiation exposure, cost, and limited availability. Currently, the standard method&#xD;
        for PNX detection is chest X-ray (CXR), but its reliability is suboptimal, resulting in&#xD;
        potential misdiagnoses and delays in patient care.&#xD;
  &#xD;
        An alternate method for detecting PNX is using lung ultrasound (LUS). LUS is safe, portable&#xD;
        compared to CXR, has the potential for faster results and higher accuracy relative to CXR.&#xD;
        LUS can also be carried out by appropriate trained nurses and medical trainees, instead of&#xD;
        requiring an expert radiographer. This prospective, single-center, observational,&#xD;
        cross-sectional, cohort, feasibility pilot trial assesses trainee-performed bedside lung&#xD;
        ultrasound (LUS) for detecting PNX and testing feasibility for a multicenter observational&#xD;
        prospective study.&#xD;
  &#xD;
        The investigators will also compare PNX detection using LUS by novices compared to experts,&#xD;
        interrater reliability and the time required from chest/mediastinal tube removal to&#xD;
        diagnostic report for LUS. All participants will undergo assessment for PNX using both LUS&#xD;
        and CXR completed independently (by study-trained critical care nurse/surgical trainee or an&#xD;
        expert radiologist, respectively) and results will be compared between the two modalities.&#xD;
  &#xD;
        The successful implementation of LUS could lead to streamlined patient care and improved&#xD;
        outcomes for cardiac surgery and trauma patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_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.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rate</measure>
      <time_frame>12 months (full pilot trial)</time_frame>
      <description>The total number of participants recruited during the pilot trial. Target: 60 participants.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence to LUS Scan Protocol</measure>
      <time_frame>12 months (full pilot trial)</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of Accurate LUS Data Collection for Comparison with Chest X-rays</measure>
      <time_frame>12 months (full pilot trial)</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Compare novice-performed LUS with CXR reports performed by experienced radiologists.</measure>
      <time_frame>12 months (full pilot trial)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnostic accuracy of LUS vs CXR</measure>
      <time_frame>12 months (full pilot trial)</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnostic Sensitivity of CXR vs LUS</measure>
      <time_frame>12 months (full pilot trial)</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interrater reliability</measure>
      <time_frame>12 months (full pilot trial)</time_frame>
      <description>Assess the interrater reliability of novice and expert sonographers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time Required</measure>
      <time_frame>12 months (full pilot trial)</time_frame>
      <description>Assess the time required from chest/mediastinal tube removal to diagnostic report for LUS vs CXR.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Pneumothorax</condition>
    <arm_group>
      <arm_group_label>Diagnostic modalities comparison</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Lung ultrasound to detect pneumothorax.</intervention_name>
      <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.</description>
      <arm_group_label>Diagnostic modalities comparison</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years old.&#xD;
  &#xD;
            -  Cardiac and trauma patients who have had a chest/mediastinal tube removed within the&#xD;
               past two hours in the CVICU, trauma bay, or ward.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who had a PNX prior to mediastinal chest tube removal that required&#xD;
               intervention.&#xD;
  &#xD;
            -  Patients on mechanical ventilation.&#xD;
  &#xD;
            -  Patients with subcutaneous emphysema due to impaired pleural line visualization.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jacobo Moreno Garijo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sunnybrook Health Sciences Centre</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jacobo Moreno Garijo, MD</last_name>
      <phone>416-480-4864</phone>
      <email>jacobo.morenogarijo@sunnybrook.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lilia Kaustov, PhD</last_name>
      <phone>416-480-6100</phone>
      <phone_ext>89607</phone_ext>
      <email>lilia.kaustov@sunnybrook.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sunnybrook Health Science Centre</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M4N 3M5</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Jacobo Moreno Garijo, MD</last_name>
        <phone>416-480-4864</phone>
        <email>jacobo.morenogarijo@sunnybrook.ca</email>
      </contact>
      <contact_backup>
        <last_name>Lilia Kaustov</last_name>
        <phone>416-480-6100</phone>
        <phone_ext>89607</phone_ext>
        <email>lilia.kaustov@sunnybrook.ca</email>
      </contact_backup>
      <investigator>
        <last_name>Jacobo Moreno Garijo, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Angela Jerath, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Colin McCartney, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Barbara Haas, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Stephen Fremes, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Gideon Cohen, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Idan Roifman, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dennis Ko, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Beth Linseman, RN</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Heather Harrington, RN</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alexander Kiss, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>18539477</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>11303163</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>12643411</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>11819085</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>20113700</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>21701019</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>32313780</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>3872573</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>20382717</PMID>
    </reference>
    <reference>
      <citation>Ball CG, Kirkpatrick AW, Feliciano DV. The occult pneumothorax: what have we learned? Can J Surg. 2009 Oct;52(5):E173-9.</citation>
      <PMID>19865549</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
      <investigator_full_name>Jacobo Moreno Garijo</investigator_full_name>
      <investigator_title>Staff Anesthesiologist</investigator_title>
    </responsible_party>
    <keyword>Pneumothorax</keyword>
    <keyword>Lung Ultrasound</keyword>
    <keyword>Chest X-Ray</keyword>
    <keyword>Trauma patients</keyword>
    <keyword>Cardiac Surgery</keyword>
    <keyword>Chest Drain Removal</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pneumothorax</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified data will be available upon request</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Upon publication, no limit on time</ipd_time_frame>
      <ipd_access_criteria>Contact study investigators</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06022081
  org study id: 5854
  nct id: NCT06022081
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention 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.
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Recruitment rate
  time frame: 12 months (full pilot trial)
  description: The total number of participants recruited during the pilot trial. Target: 60 participants.
  measure: Adherence to LUS Scan Protocol
  time frame: 12 months (full pilot trial)
  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.
  measure: Feasibility of Accurate LUS Data Collection for Comparison with Chest X-rays
  time frame: 12 months (full pilot trial)
  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.
  measure: Compare novice-performed LUS with CXR reports performed by experienced radiologists.
  time frame: 12 months (full pilot trial)
  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.
  measure: Diagnostic accuracy of LUS vs CXR
  time frame: 12 months (full pilot trial)
  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).
  measure: Diagnostic Sensitivity of CXR vs LUS
  time frame: 12 months (full pilot trial)
  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).
  measure: Interrater reliability
  time frame: 12 months (full pilot trial)
  description: Assess the interrater reliability of novice and expert sonographers.
  measure: Time Required
  time frame: 12 months (full pilot trial)
  description: Assess the time required from chest/mediastinal tube removal to diagnostic report for LUS vs CXR.
  arm group label: Diagnostic modalities comparison
  arm group type: Other
  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: Lung ultrasound to detect pneumothorax.
  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.
  arm group label: Diagnostic modalities comparison
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jacobo Moreno Garijo, MD
  role: Principal Investigator
  affiliation: Sunnybrook Health Sciences Centre
  last name: Jacobo Moreno Garijo, MD
  phone: 416-480-4864
  email: jacobo.morenogarijo@sunnybrook.ca
  last name: Lilia Kaustov, PhD
  phone: 416-480-6100
  phone ext: 89607
  email: lilia.kaustov@sunnybrook.ca
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Canada
  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.
  PMID: 18539477
  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.
  PMID: 11303163
  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.
  PMID: 12643411
  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.
  PMID: 11819085
  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.
  PMID: 20113700
  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.
  PMID: 21701019
  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.
  PMID: 32313780
  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.
  PMID: 3872573
  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.
  PMID: 20382717
  citation: Ball CG, Kirkpatrick AW, Feliciano DV. The occult pneumothorax: what have we learned? Can J Surg. 2009 Oct;52(5):E173-9.
  PMID: 19865549
  responsible party type: Principal Investigator
  investigator affiliation: Sunnybrook Health Sciences Centre
  investigator full name: Jacobo Moreno Garijo
  investigator title: Staff Anesthesiologist
  mesh term: Pneumothorax
  sharing ipd: Yes
  ipd description: De-identified data will be available upon request
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Upon publication, no limit on time
  ipd access criteria: Contact study investigators