PneumothoraxCLEARVGRDNCT07018856
Feasibility Study of Novice-Performed Lung Ultrasound for Pneumothorax Detection After Cardiac Surgery
An observational study of Pneumothorax and Cardiac Surgery, run by Jacobo Moreno Garijo at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax, Cardiac Surgery, Lung Ultrasound
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 16 Sep 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age 18 years or older
- Undergoing cardiac surgery
- Scheduled for chest and/or mediastinal chest tube removal in the cardiovascular intensive care unit (CVICU)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Lilia Kaustov, MSc, PhD, 416-480-6100 ext. 89607, lilia.kaustov@sunnybrook.ca
Eva Delavinias, 416-880-5924, eva.delavinias@sunnybrook.ca
About this study
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
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.
Read more
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.
Read the 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.
- 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
- Medical subject headings
- Pneumothorax, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months after study start
Secondary outcomes (4)
Diagnostic Agreement Between Novice-Performed Lung Ultrasound and Chest X-Ray for Pneumothorax Detection
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.
Measured: Up to 2 hours after chest tube removal on Day 0
Time to Diagnosis: Lung Ultrasound vs. Chest X-Ray
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.
Measured: Up to 2 hours after chest tube removal on Day 0
Patient-Reported Experience With Lung Ultrasound
Assess patient-reported comfort, acceptability, and imaging preference using a short questionnaire with Likert-scale responses following lung ultrasound.
Measured: Immediately after lung ultrasound on Day 0
Adverse Events Related to Missed Pneumothorax
Monitor for complications associated with missed or delayed pneumothorax diagnosis, including respiratory failure, chest tube reinsertion, ICU readmission, or in-hospital mortality.
Measured: From chest tube removal through hospital discharge (up to 14 days, based on the expected max stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start16 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacobo Moreno Garijo
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Toronto General Hospital, London Health Sciences Centre
- Responsible party
- Sponsor-investigator, Jacobo Moreno Garijo, Sunnybrook Health Sciences Centre
- Investigators
- Angela Jerath, MD, Study chair, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018856
- Sponsor's protocol ID
- 5321
- Other IDs
- AFP2024-25-SB
- Acronym
- CLEARVGRD
- Status last verified
- Dec 2025
- First submitted
- 21 May 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, no decision has been made regarding the sharing of individual participant data (IPD). The primary aim of this study is to assess feasibility and diagnostic accuracy in a small, multicenter pilot cohort. If future analysis supports broader data sharing and aligns with institutional ethics and privacy policies, a data-sharing plan may be developed for the larger, definitive trial.
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.
PubMed 21615445Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.
PubMed 10501650Dessie 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.
PubMed 36165271Lichtenstein 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.
PubMed 11126253Lichtenstein 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.
PubMed 10342512Lichtenstein 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.
PubMed 7587439Volpicelli 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.
PubMed 22392031Volpicelli 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.
PubMed 21103861Unluer 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.
PubMed 24793725Mumoli 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.
PubMed 26945396Shostak 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.
PubMed 23716522Raja 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.
PubMed 22841178Saucier 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.
PubMed 20118702Tocino 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.
PubMed 3872573Lin EC. Radiation risk from medical imaging. Mayo Clin Proc. 2010 Dec;85(12):1142-6; quiz 1146. doi: 10.4065/mcp.2010.0260.
PubMed 21123642
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07018856
- Acronym / sponsor ID
- CLEARVGRD / 5321
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jacobo Moreno GarijoUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Toronto General Hospital, London Health Sciences Centre
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Undergoing cardiac surgery
- Scheduled for chest and/or mediastinal chest tube removal in the cardiovascular intensive care unit (CVICU)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 21615445McAlinden 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.
- Background: PubMed 10501650Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.
- Background: PubMed 36165271Dessie 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.
- Background: PubMed 11126253Lichtenstein 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.
- Background: PubMed 10342512Lichtenstein 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.
- Background: PubMed 7587439Lichtenstein 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.
- Background: PubMed 22392031Volpicelli 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.
- Background: PubMed 21103861Volpicelli 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.
- Background: PubMed 24793725Unluer 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.
- Background: PubMed 26945396Mumoli 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.
- Background: PubMed 23716522Shostak 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.
- Background: PubMed 22841178Raja 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.
- Individual participant dataSharing planned: Undecided. At this time, no decision has been made regarding the sharing of individual participant data (IPD). The primary aim of this study is to assess feasibility and diagnostic accuracy in a small, multicenter pilot cohort. If future analysis supports broader data sharing and aligns with institutional ethics and privacy policies, a data-sharing plan may be developed for the larger, definitive trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Jerath, MD study chair
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax and Cardiac Surgery, run by Jacobo Moreno Garijo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacobo Moreno Garijo, MD, PhD (416-480-4864, jacobo.morenogarijo@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate Across Sites (time frame: Up to 12 months after study start). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07018856, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.