PneumothoraxNCT04678726
Nurse-performed Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax.
An observational study of Pneumothorax and Cardiac Surgery, run by University Health Network, Toronto.
Trial summary
This is a prospective, single-center, observational, cross-sectional cohort study, comparing nurse-performed bedside lung ultrasound to standard portable CXR, for the detection of pneumothorax in the cardiac surgery patient population, following chest tube removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax, Cardiac Surgery
- What is being tested?
- Lung ultrasound assessment for ruling out pneumothorax
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: CVICU patients after cardiac surgery
Who may be able to join
- Patients older than 18 years in the cardiovascular intensive care unit post cardiac surgery, with a chest tube removed within the past 2 hours.
Who cannot join
- Patients who were mechanically ventilated or with subcutaneous emphysema due to impaired pleural line visualization.
About this study
Official title: Nurse-performed Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax After Mediastinal Drainage Removal Post Cardiac Surgery.
This is a prospective, single-center, observational, cross-sectional cohort study, comparing nurse-performed bedside lung ultrasound to standard portable CXR, for the detection of pneumothorax in the cardiac surgery patient population, following chest tube removal. This study aims to be conducted at an academic, tertiary adult center cardio-vascular intensive care unit (CVICU at TGH).
Read the detailed description
To avoid the accumulation of blood and fluids in the mediastinum or pleural cavities after cardiac surgery, mediastinal and pleural drains are routinely used. The rate of pneumothorax following chest drain removal is approximately 1.5-13%, resulting in increased patient morbidity and hospital stay. The standard method for the determination of pneumothorax (PNX) in most institutions is to obtain a chest radiography (CXR) following chest tube removal, but the reliability of the supine anteroposterior chest radiography is not utter, with up to 30% of pneumothoraxes misdiagnosis. The delay of ordering, performing and interpreting a CXR post mediastinal tube removal, results in potential delay in patients transfers, with an estimated cost savings of omitting an additional chest radiography, of approximately $10 000 per year.
Lung ultrasound (LUS) is recommended for detection of pneumothorax as per evidence-based guidelines and expert consensus. Lung ultrasound is a safe technique due to minimal radiation, with the potential for immediate results when compared with the standard CXR. LUS has high accuracy for PNX detection, with better pooled sensitivities (78.6%) when compared to CXR (39.8%) and equal specificity (98.4 vs 99.3%). In intensive care units, those results have been reproducible, with LUS having greater sensitivity than CXR for PNX diagnosis (0.87 vs 0.46) and equal specificity, 0.99 vs 1.00. LUS is more accurate and faster than chest radiography.
- Conditions
- Pneumothorax, Cardiac Surgery
- Being tested
- Lung ultrasound assessment for ruling out pneumothorax
- Keywords
- Chest tube removal
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound assessment for ruling out pneumothoraxDiagnostic test
Also called Portable chest x-ray
Patients who have undergone heart surgery and have decided to enroll in our study, will have the standard chest x-ray and an additional lung ultrasound. Within a maximum of two hours of the chest tube removal, the standard chest x-ray will be performed, and then a different nurse will perform the lung ultrasound to check for pneumothorax.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Pneumothorax
Assess the accuracy of nurse-performed lung ultrasound in the diagnosis of pneumothorax post chest tube removal after cardiac surgery compared to chest x-ray.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study startJul 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: COVID interference in the ability to initiate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacobo Moreno Garijo, MD, Principal investigator, Sunnybrook Health Sciences CentreAzad Mashari, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678726
- Sponsor's protocol ID
- 17-6203
- Status last verified
- Nov 2022
- First submitted
- 16 Dec 2020
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-performed Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax After Mediastinal Drainage Removal Post Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT04678726
- Acronym / sponsor ID
- 17-6203
- Conditions
- Pneumothorax, Cardiac Surgery
- Keywords
- Chest tube removal
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID interference in the ability to initiate the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Dec 2020 (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.
This is a prospective, single-center, observational, cross-sectional cohort study, comparing nurse-performed bedside lung ultrasound to standard portable CXR, for the detection of pneumothorax in the cardiac surgery patient population, following chest tube removal. This study aims to be conducted at an academic, tertiary adult center cardio-vascular intensive care unit (CVICU at TGH).
Detailed description
To avoid the accumulation of blood and fluids in the mediastinum or pleural cavities after cardiac surgery, mediastinal and pleural drains are routinely used. The rate of pneumothorax following chest drain removal is approximately 1.5-13%, resulting in increased patient morbidity and hospital stay. The standard method for the determination of pneumothorax (PNX) in most institutions is to obtain a chest radiography (CXR) following chest tube removal, but the reliability of the supine anteroposterior chest radiography is not utter, with up to 30% of pneumothoraxes misdiagnosis. The delay of ordering, performing and interpreting a CXR post mediastinal tube removal, results in potential delay in patients transfers, with an estimated cost savings of omitting an additional chest radiography, of approximately $10 000 per year.
Lung ultrasound (LUS) is recommended for detection of pneumothorax as per evidence-based guidelines and expert consensus. Lung ultrasound is a safe technique due to minimal radiation, with the potential for immediate results when compared with the standard CXR. LUS has high accuracy for PNX detection, with better pooled sensitivities (78.6%) when compared to CXR (39.8%) and equal specificity (98.4 vs 99.3%). In intensive care units, those results have been reproducible, with LUS having greater sensitivity than CXR for PNX diagnosis (0.87 vs 0.46) and equal specificity, 0.99 vs 1.00. LUS is more accurate and faster than chest radiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CVICU patients after cardiac surgery
Key inclusion criteria (1 listed)
- Patients older than 18 years in the cardiovascular intensive care unit post cardiac surgery, with a chest tube removed within the past 2 hours.
Key exclusion criteria (1 listed)
- Patients who were mechanically ventilated or with subcutaneous emphysema due to impaired pleural line visualization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasound assessment for ruling out pneumothoraxAlso: Portable chest x-rayPatients who have undergone heart surgery and have decided to enroll in our study, will have the standard chest x-ray and an additional lung ultrasound. Within a maximum of two hours of the chest tube removal, the standard chest x-ray will be performed, and then a different nurse will perform the lung ultrasound to check for pneumothorax. | Diagnostic test | – |
Primary outcome
Diagnosis of Pneumothorax
Time frame: 24 months
Assess the accuracy of nurse-performed lung ultrasound in the diagnosis of pneumothorax post chest tube removal after cardiac surgery compared to chest x-ray.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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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. This study is not recruiting at the moment.
Jacobo Moreno Garijo, MD principal investigator
Sunnybrook Health Sciences Centre
Azad Mashari, MD principal investigator
University Health Network, Toronto
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax and Cardiac Surgery, run by University Health Network, Toronto.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Pneumothorax (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2024.