Recruiting

Lung Ultrasound

Sponsor:

Jacobo Moreno Garijo

Code:

NCT07018856

Conditions

Pneumothorax

Cardiac Surgery

Lung Ultrasound

Chest Tube Removal

Postoperative Complications (Cardiopulmonary)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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)

Study ID

NCT07018856

Start date

Sep 16, 2025

Status verified date

Dec, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Recruitment Rate Across Sites [ Time Frame: Up to 12 months after study start ]
  • Protocol Adherence to Lung Ultrasound Procedures [ Time Frame: Up to 12 months after study start ]
  • Participant Attrition Rate [ Time Frame: Up to 12 months after study start ]
  • Inter-Rater Agreement Between Novice and Expert Ultrasound Reviewers [ Time Frame: Up to 12 months after study start ]

Central Contacts and Locations

Central contacts

Jacobo Moreno Garijo, MD, PhD

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

Lilia Kaustov, MSc, PhD

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

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Lilia Kaustov, MSc, PhD

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

Eva Delavinias

416-880-5924eva.delavinias@sunnybrook.ca

Principal Investigator:

Jacobo Moreno Garijo, MD, PhD

More Information

Sponsor

Jacobo Moreno Garijo

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jacobo Moreno Garijo on 2025-12-24.