Actively Recruiting

Age: 18Years +
All Genders
ID07018856

The CLEAR Vanguard Feasibility Study: Evaluating Novice-Performed Lung Ultrasound Compared to Chest X-Ray for Pneumothorax Detection After Chest Tube Removal in Cardiac Surgery Patients

Led by Jacobo Moreno Garijo · Updated on 2025-12-24

120

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

J

Jacobo Moreno Garijo

Lead Sponsor

S

Sunnybrook Health Sciences Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether medical trainees, such as residents and fellows, can learn to use lung ultrasound to detect pneumothorax (collapsed lung) after heart surgery. This study focuses on adults who have recently undergone cardiac surgery and are having their chest tubes removed in the intensive care unit. The purpose is to test if lung ultrasound can be safely and accurately performed by trainees instead of the usual chest X-ray, with results reviewed by expert doctors to plan future larger studies. In this observational study, trained medical trainees will perform lung ultrasound exams at the bedside within two hours after chest tube removal. Each patient will also receive a standard chest X-ray for comparison. The study takes place at three large hospitals and includes about 120 patients. No treatments are assigned; the study compares two diagnostic methods to assess their agreement and reliability. Participants will undergo lung ultrasound and chest X-ray assessments, with researchers monitoring how well trainees follow the procedure and comparing their results to experts' reviews. Patient experiences of having bedside ultrasound will also be collected. Outcomes include recruitment rate, protocol adherence, participant dropout, and diagnostic agreement. Safety is monitored for adverse events related to missed pneumothorax during hospital stay, with study involvement lasting up to 12 months for these evaluations.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Undergoing cardiac surgery
  • Scheduled for chest and/or mediastinal chest tube removal in the cardiovascular intensive care unit (CVICU)
Not Eligible

You will not qualify if you...

  • Severe chronic lung disease that may impair lung ultrasound interpretation, such as subcutaneous emphysema
  • COPD or emphysema with FEV1 less than 50% predicted
  • Interstitial lung disease with FEV1 less than 75% predicted
  • History of pneumothorax before chest tube removal requiring intervention
  • Mechanical ventilation at the time of screening
  • Unable to undergo lung ultrasound or chest X-ray due to hemodynamic instability or positioning issues

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 2 hours after chest tube removal on Day 0

Participants undergo lung ultrasound performed by trained medical trainees and a standard chest X-ray to detect pneumothorax after chest tube removal.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 14 days

Participants are monitored for adverse events related to pneumothorax from chest tube removal through hospital discharge.

Approximately 1 to 2 follow-up assessments during hospital stay

Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

J

Jacobo Moreno Garijo, MD, PhD

L

Lilia Kaustov, MSc, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

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Colm McAlinden, Jyoti Khadka, Konrad Pesudovs

https://pubmed.ncbi.nlm.nih.gov/21615445

Development and Validation of a Point-of-Care-Ultrasound Image Quality Assessment Tool: The POCUS IQ Scale.

Almaz S Dessie, Aaron W Calhoun, Panida Kanjanauptom...

https://pubmed.ncbi.nlm.nih.gov/36165271

Accuracy of Nurse-Performed Lung Ultrasound in Patients With Acute Dyspnea: A Prospective Observational Study.

Nicola Mumoli, Josè Vitale, Matteo Giorgi-Pierfranceschi...

https://pubmed.ncbi.nlm.nih.gov/26945396