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Recruiting NCT07018856

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

— Observational Pneumothorax Cardiac Surgery Lung Ultrasound Chest Tube Removal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pneumothorax, Cardiac Surgery, Lung Ultrasound, Chest Tube Removal. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Detailed description

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.

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • 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]
  • Time to Diagnosis: Lung Ultrasound vs. Chest X-Ray [Time frame: Up to 2 hours after chest tube removal on Day 0]
  • Patient-Reported Experience With Lung Ultrasound [Time frame: Immediately after lung ultrasound on Day 0]
  • 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Sunnybrook Health Sciences Centre — Toronto

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 Conse PMID 22392031
  • 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

Identifiers

NCT: NCT07018856 · 5321 · AFP2024-25-SB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗