Feasibility Study of Novice-Performed Lung Ultrasound for Pneumothorax Detection After Cardiac Surgery

NCT07018856 | Recruiting

• 2 other identifiers: 5321AFP2024-25-SB
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

What is the purpose of this study? This study is being done to find out if medical trainees (such as residents and fellows) can learn to use lung ultrasound to detect a collapsed lung (pneumothorax) after heart surgery. Who is participating in the study? Adults who have recently had heart surgery and are having their chest tubes removed in the intensive care unit may be able to join. What will happen during the study? After chest tubes are removed, a trained medical trainee will use a small ultrasound device to check the lungs at the bedside. The patient will also have a chest X-ray, which is the usual test. The results from the ultrasound will be compared to the chest X-ray and reviewed by expert doctors. What is the goal of the study? The goal is to see if it is possible to train medical trainees to use lung ultrasound safely and accurately in real hospital settings. The results will help plan a larger study in the future.

Conditions

Pneumothorax; Cardiac Surgery; Lung Ultrasound; Chest Tube Removal; Postoperative Complications (Cardiopulmonary)

Keywords

Lung Ultrasound; Pneumothorax Detection; Chest Tube Removal; Cardiac Surgery; Point-of-Care Ultrasound; Postoperative Complication; Bedside Ultrasound; Novice Sonographer; Diagnostic Accuracy; Feasibility Study; Critical Care Ultrasound; Trainee-Performed Ultrasound; Chest X-Ray; Medical Education

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate Across Sites

  Recruitment feasibility will be measured by the number of participants enrolled per site per month. The target is at least 2 patients per site per month across three participating centers. Unit of Measure: Participants per site per month

  Up to 12 months after study start

• Protocol Adherence to Lung Ultrasound Procedures

  Percentage of enrolled participants with complete protocol adherence, defined as having both lung ultrasound and chest X-ray performed and documented as per protocol, including all required images and forms. Unit of Measure: Percentage.

  Up to 12 months after study start

• Participant Attrition Rate

  Percentage of enrolled participants who withdraw or are lost to follow-up before completion of study procedures. The study aims to maintain an attrition rate below 10%. Unit of Measure: Percentage.

  Up to 12 months after study start

• Inter-Rater Agreement Between Novice and Expert Ultrasound Reviewers

  Inter-rater reliability for lung ultrasound interpretation between novice trainees and expert reviewers, measured using kappa statistics. The target agreement is a kappa ≥ 0.8. Unit of Measure: Kappa statistic.

  Up to 12 months after study start

Secondary Outcomes (4)

• Diagnostic Agreement Between Novice-Performed Lung Ultrasound and Chest X-Ray for Pneumothorax Detection

  Up to 2 hours after chest tube removal on Day 0

• Time to Diagnosis: Lung Ultrasound vs. Chest X-Ray

  Up to 2 hours after chest tube removal on Day 0

• Patient-Reported Experience With Lung Ultrasound

  Immediately after lung ultrasound on Day 0

• Adverse Events Related to Missed Pneumothorax

  From chest tube removal through hospital discharge (up to 14 days, based on the expected max stay)

Other Outcomes (2)

• Diagnostic Sensitivity and Specificity of Lung Ultrasound vs. Chest X-Ray

  Within 2 hours of chest tube removal

• Image Quality Scores of Trainee-Performed Lung Ultrasound

  Immediately following each lung ultrasound (same day as chest tube removal)

Study Arms (1)

Post-Cardiac Surgery Patients Undergoing Chest Tube Removal

This cohort includes adult patients who have undergone cardiac surgery and are scheduled for chest and/or mediastinal chest tube removal in the cardiovascular intensive care unit. Each participant will undergo a lung ultrasound performed by a trained medical trainee and a standard chest X-ray to assess for pneumothorax. No interventions are assigned; this is an observational comparison of two diagnostic modalities.

Eligibility Criteria

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

Study Population

This study will enroll adult patients (18 years or older) who have undergone cardiac surgery and are scheduled for chest and/or mediastinal chest tube removal in the cardiovascular intensive care unit (CVICU). Participants will be recruited from three high-volume cardiac centers in Ontario, Canada: Sunnybrook Health Sciences Centre, Toronto General Hospital, and London Health Sciences Centre. Patients must be able to safely undergo both lung ultrasound and chest X-ray after chest tube removal. Individuals with severe lung disease or who are mechanically ventilated at the time of eligibility screening will be excluded.

You may qualify if:

• Age 18 years or older
• Undergoing cardiac surgery
• Scheduled for chest and/or mediastinal chest tube removal in the cardiovascular intensive care unit (CVICU)

You may not qualify if:

• Severe chronic lung disease that may impair lung ultrasound interpretation, including:
• Subcutaneous emphysema
• COPD or emphysema with FEV₁ \< 50% predicted
• Interstitial lung disease with FEV₁ \< 75% predicted
• Documented history of pneumothorax prior to chest tube removal requiring intervention
• Mechanical ventilation at the time of eligibility screening
• Inability to undergo lung ultrasound or chest X-ray (e.g., due to hemodynamic instability or positioning limitations)

Sponsors & Collaborators

• Jacobo Moreno Garijo: lead
• Sunnybrook Health Sciences Centre: collaborator
• Toronto General Hospital: collaborator
• London Health Sciences Centre: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Related Publications (21)

• McAlinden C, Khadka J, Pesudovs K. Statistical methods for conducting agreement (comparison of clinical tests) and precision (repeatability or reproducibility) studies in optometry and ophthalmology. Ophthalmic Physiol Opt. 2011 Jul;31(4):330-8. doi: 10.1111/j.1475-1313.2011.00851.x. Epub 2011 May 26.

  PMID: 21615445 BACKGROUND

• Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.

  PMID: 10501650 BACKGROUND

• Dessie AS, Calhoun AW, Kanjanauptom P, Gilbert GE, Ekpenyong A, Lewiss RE, Rabiner JE, Tsze DS, Kessler DO. Development and Validation of a Point-of-Care-Ultrasound Image Quality Assessment Tool: The POCUS IQ Scale. J Ultrasound Med. 2023 Jan;42(1):135-145. doi: 10.1002/jum.16095. Epub 2022 Sep 27.

  PMID: 36165271 BACKGROUND

• Lichtenstein D, Meziere G, Biderman P, Gepner A. The "lung point": an ultrasound sign specific to pneumothorax. Intensive Care Med. 2000 Oct;26(10):1434-40. doi: 10.1007/s001340000627.

  PMID: 11126253 BACKGROUND

• Lichtenstein D, Meziere G, Biderman P, Gepner A. The comet-tail artifact: an ultrasound sign ruling out pneumothorax. Intensive Care Med. 1999 Apr;25(4):383-8. doi: 10.1007/s001340050862.

  PMID: 10342512 BACKGROUND

• Lichtenstein DA, Menu Y. A bedside ultrasound sign ruling out pneumothorax in the critically ill. Lung sliding. Chest. 1995 Nov;108(5):1345-8. doi: 10.1378/chest.108.5.1345.

  PMID: 7587439 BACKGROUND

• Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

  PMID: 22392031 BACKGROUND

• Volpicelli G. Sonographic diagnosis of pneumothorax. Intensive Care Med. 2011 Feb;37(2):224-32. doi: 10.1007/s00134-010-2079-y. Epub 2010 Nov 20.

  PMID: 21103861 BACKGROUND

• Unluer EE, Karagoz A, Oyar O, Vandenberk N, Kiyancicek S, Budak F. Lung ultrasound by emergency nursing as an aid for rapid triage of dyspneic patients: a pilot study. Int Emerg Nurs. 2014 Oct;22(4):226-31. doi: 10.1016/j.ienj.2014.03.003. Epub 2014 Apr 2. No abstract available.

  PMID: 24793725 BACKGROUND

• Mumoli N, Vitale J, Giorgi-Pierfranceschi M, Cresci A, Cei M, Basile V, Brondi B, Russo E, Giuntini L, Masi L, Cocciolo M, Dentali F. Accuracy of Nurse-Performed Lung Ultrasound in Patients With Acute Dyspnea: A Prospective Observational Study. Medicine (Baltimore). 2016 Mar;95(9):e2925. doi: 10.1097/MD.0000000000002925.

  PMID: 26945396 BACKGROUND

• Shostak E, Brylka D, Krepp J, Pua B, Sanders A. Bedside sonography for detection of postprocedure pneumothorax. J Ultrasound Med. 2013 Jun;32(6):1003-9. doi: 10.7863/ultra.32.6.1003.

  PMID: 23716522 BACKGROUND

• Raja AS, Jacobus CH. How accurate is ultrasonography for excluding pneumothorax? Ann Emerg Med. 2013 Feb;61(2):207-8. doi: 10.1016/j.annemergmed.2012.07.005. Epub 2012 Jul 27. No abstract available.

  PMID: 22841178 BACKGROUND

• Saucier S, Motyka C, Killu K. Ultrasonography versus chest radiography after chest tube removal for the detection of pneumothorax. AACN Adv Crit Care. 2010 Jan-Mar;21(1):34-8. doi: 10.1097/NCI.0b013e3181c8013a.

  PMID: 20118702 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

• Lin EC. Radiation risk from medical imaging. Mayo Clin Proc. 2010 Dec;85(12):1142-6; quiz 1146. doi: 10.4065/mcp.2010.0260.

  PMID: 21123642 BACKGROUND

• Omar HR, Mangar D, Khetarpal S, Shapiro DH, Kolla J, Rashad R, Helal E, Camporesi EM. Anteroposterior chest radiograph vs. chest CT scan in early detection of pneumothorax in trauma patients. Int Arch Med. 2011 Sep 27;4(1):30. doi: 10.1186/1755-7682-4-30.

  PMID: 21951659 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

• Roberts DJ, Leigh-Smith S, Faris PD, Blackmore C, Ball CG, Robertson HL, Dixon E, James MT, Kirkpatrick AW, Kortbeek JB, Stelfox HT. Clinical Presentation of Patients With Tension Pneumothorax: A Systematic Review. Ann Surg. 2015 Jun;261(6):1068-78. doi: 10.1097/SLA.0000000000001073.

  PMID: 25563887 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

• 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

• 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

MeSH Terms

Conditions

Pneumothorax; Postoperative Complications

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angela Jerath, MD

  Sunnybrook Health Sciences Centre

  STUDY CHAIR

Central Study Contacts

Jacobo Moreno Garijo, MD, PhD

CONTACT

416-480-4864; jacobo.morenogarijo@sunnybrook.ca

Lilia Kaustov, MSc, PhD

CONTACT

416-480-6100; lilia.kaustov@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Jacobo Moreno Garijo, MD, MSc, PhD, FASE - Principal Investigator and Cardiac Anesthesiologist, Sunnybrook Health Sciences Centre; Assistant Professor, University of Toronto

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 13, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

CA (1)