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NCT Number: NCT07018856

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

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.

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Key information

Conditions

Pneumothorax Cardiac Surgery Chest Tube Removal Lung Ultrasound Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Postoperative Complications Postoperative Complications (Cardiopulmonary) Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Alexander Kiss, PhD

SUB_INVESTIGATOR

Angela Jerath, MD

SUB_INVESTIGATOR

Colin McCartney, MD

SUB_INVESTIGATOR

Dennis Ko, MD

SUB_INVESTIGATOR

Eva Delavinias

CONTACT

[email protected]

416-880-5924

Gideon Cohen, MD, PhD

SUB_INVESTIGATOR

Idan Roifman, MD

SUB_INVESTIGATOR

Jacobo Moreno Garijo, MD, PhD

PRINCIPAL_INVESTIGATOR

John Basmaji, MD

SUB_INVESTIGATOR

Justyna Bartoszko, MD

SUB_INVESTIGATOR

Lilia Kaustov, MSc, PhD

CONTACT

[email protected]

416-480-6100 ext. 89607

Lilia Kaustov, MSc, PhD

SUB_INVESTIGATOR

Marat Slessarev, MD

SUB_INVESTIGATOR

Naheed Jivraj, MD, MSc

SUB_INVESTIGATOR

Neill Adhikari, MD, MSc

SUB_INVESTIGATOR

Stephen Fremes, MD, MSc

SUB_INVESTIGATOR

Wilfredo Puentes, MD

SUB_INVESTIGATOR

About this study

This is a feasibility study to test whether lung ultrasound can be used by medical trainees to detect pneumothorax (collapsed lung) after heart surgery, instead of using a chest X-ray.

Collapsed lungs can happen after chest tubes are removed, which is a common step after heart surgery. While chest X-rays are usually used to check for this, they can sometimes miss cases or take time to complete. Lung ultrasound is a fast, safe, and radiation-free tool that can be done right at the bedside.

In this study, medical trainees-such as anesthesia residents, critical care fellows, or internal medicine residents-will receive focused training on how to use lung ultrasound. After training, they will perform lung ultrasound exams on patients within two hours after chest tube removal. These results will be compared to chest X-rays, and also reviewed by expert doctors who are blinded to the trainee's findings.

The study will take place at three large hospitals in Ontario, Canada. It will include about 120 patients in total. The study team will look at how well trainees follow the protocol, how accurate their ultrasound readings are, and how patients feel about having ultrasound done at the bedside.

This study does not involve any new treatments or medications. The purpose is to see if lung ultrasound can be safely and effectively performed by trainees, and whether a larger study should be done in the future to confirm its benefits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Recruitment Rate Across Sites

    Time frame: Up to 12 months after study start

    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

  2. Protocol Adherence to Lung Ultrasound Procedures

    Time frame: Up to 12 months after study start

    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.

  3. Participant Attrition Rate

    Time frame: Up to 12 months after study start

    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.

  4. Inter-Rater Agreement Between Novice and Expert Ultrasound Reviewers

    Time frame: Up to 12 months after study start

    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.

Secondary outcomes

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

    Time frame: Up to 2 hours after chest tube removal on Day 0

    This outcome compares the diagnostic accuracy of lung ultrasound performed by trained medical trainees to standard chest X-ray for pneumothorax detection following chest tube removal. Agreement will be assessed using kappa statistics. Expert reviewers will independently evaluate LUS images while radiologists will interpret CXR images, both blinded to each other's findings.

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

    Time frame: Up to 2 hours after chest tube removal on Day 0

    Compare the time from chest tube removal to pneumothorax diagnosis using lung ultrasound versus chest X-ray. Time will be measured in minutes from tube removal to the documented result of each imaging modality.

  3. Patient-Reported Experience With Lung Ultrasound

    Time frame: Immediately after lung ultrasound on Day 0

    Assess patient-reported comfort, acceptability, and imaging preference using a short questionnaire with Likert-scale responses following lung ultrasound.

  4. Adverse Events Related to Missed Pneumothorax

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

    Monitor for complications associated with missed or delayed pneumothorax diagnosis, including respiratory failure, chest tube reinsertion, ICU readmission, or in-hospital mortality.

Other outcomes

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

    Time frame: Within 2 hours of chest tube removal

    Sensitivity and specificity of novice-performed lung ultrasound will be calculated for pneumothorax detection, using expert-reviewed chest X-ray as the clinical standard.

  2. Image Quality Scores of Trainee-Performed Lung Ultrasound

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

    Expert reviewers will assess image quality using a 3-point scale (inadequate, adequate, optimal) for each LUS exam performed by trainees. The proportion of adequate or better images will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacobo Moreno Garijo, MD, PhD

CONTACT

[email protected]

416-480-4864

Lilia Kaustov, MSc, PhD

CONTACT

[email protected]

416-480-6100 ext. 89607

Sponsors and collaborators

Lead sponsor

Jacobo Moreno Garijo

Other

Collaborators

  • London Health Sciences Centre
  • Sunnybrook Health Sciences Centre
  • Toronto General Hospital

Registry information

Official study title

The CLEAR Vanguard Feasibility Study: Comparative Evaluation of Novice-Performed Lung Ultrasound Versus Chest X-Ray for Pneumothorax Detection Post-Chest Tube Removal in Cardiac Surgery Patients

Acronym: CLEARVGRD

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 13, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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