PneumothoraxNCT03397290
Bedside Ultrasound in Detection of Pneumothorax Post Transthoracic Lung Biopsy
A study testing Ultrasound (US) Imaging in people with Pneumothorax, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Currently chest X-ray (CXR) is the modality used to assess for pneumothorax after transthoracic lung biopsy at the Ottawa Hospital. Recently bedside Ultrasound (US) has become a useful rapid imaging modality to assess chest for pneumothorax in emergency rooms with reported sensitivity, specificity and diagnostic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Ultrasound (US) Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 25 May 2018to 26 Feb 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are booked and coming for image-guided transthoracic biopsy of a lung lesion to the Ottawa Hospital, General Campus, will be consented and those who agree to added US will be included
Who cannot join
- Other patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Bedside Ultrasound in Detection of Pneumothorax Post Transthoracic Lung
Currently chest X-ray (CXR) is the modality used to assess for pneumothorax after transthoracic lung biopsy at the Ottawa Hospital. Recently bedside Ultrasound (US) has become a useful rapid imaging modality to assess chest for pneumothorax in emergency rooms with reported sensitivity, specificity and diagnostic accuracy were 88%, 97% and 97%, respectively (ref. 2).
Our team will be comparing the diagnostic accuracy of US to CXR in diagnoses of pneumothorax post transthoracic lung biopsy.
The purpose of the study is to compare the diagnostic accuracy of US to CXR post-biopsy to confirm the presence of a pneumothorax.
Read the detailed description
Hypothesis:
US have sensitivity and specificity equal or better than CXR to exclude pneumothorax after transthoracic lung biopsy.
Clinical relevance:
Pneumothorax is a well-known complication of image-guided transthoracic biopsy of lung lesions. The incidence of pneumothorax in patients undergoing TTNB has been reported to be from 9% to 54% (ref. 3). Most of the time, the pneumothorax is small and requires no further intervention other than observation and a repeat CXR to ensure stability or resolution of the pneumothorax. In small group of patients with detected pneumothorax after biopsy, the pneumothorax is either large or becomes larger (more than 2 cm width at the level of the hilum) during observation. In these cases, a small pleural drainage catheter will be inserted to prevent the lung from collapsing. The catheter will be removed in 2 days. Detection of pneumothorax post biopsy is important to prevent possible lung collapse after discharge and currently is done by obtaining a CXR, 30 minutes after the biopsy.
Obtaining a CXR, requires moving the patient on stretcher to the X-ray room, bringing the patient to upright position, patient holds breath. An X-ray technologist obtains the CXR which will be reviewed by a Radiologist when it becomes available on work station. Then the Radiologist revisits the patient and orders the discharge.
Detection of pneumothorax by US is feasible and compare to current practice with CXR, is faster and do not need moving and repositioning the patient, therefore, more convenient. It can be easily performed at the time of clinical assessment prior to discharge.
Study design/ Methodology:
- All patients coming for lung biopsy will be invited to participate in this study. Information about the one additional US at the time of their biopsy and routine CXR will be explained to the patient by either thoracic radiology fellow or staff radiologist.
- For those who agree to participate, informed Consent will be obtained by the same people mentioned above.
- There will be no change in clinical assessment or decision to discharge the patient after biopsy.
- US will be performed by a trained staff radiologist or thoracic fellow.
- Conditions
- Pneumothorax
- Being tested
- Ultrasound (US) Imaging
- Keywords
- Chest X-ray, Ultrasound
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound (US) ImagingDevice
Ultrasound (US) Imaging will be compared to the chest X-ray for diagnostic accuracy (sensitivity and specificity) in diagnoses of pneumothorax post transthoracic lung biopsy
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Imaging | Experimental | A Single Ultrasound Imaging to diagnose of pneumothorax post transthoracic lung biopsy. Receives: Device: Ultrasound (US) Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
To determine if the sensitivity and specificity of US is equal or better than routine CXR in diagnosing pneumothorax post lung biopsy.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start25 May 2018
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betty Anne Schwarz, Ph.D., Study director, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397290
- Sponsor's protocol ID
- 20170774-01H
- Status last verified
- Sep 2021
- First submitted
- 31 Oct 2017
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Quick JA, Uhlich RM, Ahmad S, Barnes SL, Coughenour JP. In-flight ultrasound identification of pneumothorax. Emerg Radiol. 2016 Feb;23(1):3-7. doi: 10.1007/s10140-015-1348-z. Epub 2015 Sep 25.
PubMed 26407979Shostak 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 23716522Boskovic T, Stanic J, Pena-Karan S, Zarogoulidis P, Drevelegas K, Katsikogiannis N, Machairiotis N, Mpakas A, Tsakiridis K, Kesisis G, Tsiouda T, Kougioumtzi I, Arikas S, Zarogoulidis K. Pneumothorax after transthoracic needle biopsy of lung lesions under CT guidance. J Thorac Dis. 2014 Mar;6 Suppl 1(Suppl 1):S99-S107. doi: 10.3978/j.issn.2072-1439.2013.12.08.
PubMed 24672704
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Bedside Ultrasound in Detection of Pneumothorax Post Transthoracic Lung
- ClinicalTrials.gov ID
- NCT03397290
- Acronym / sponsor ID
- 20170774-01H
- Conditions
- Pneumothorax
- Keywords
- Chest X-ray, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 11 Jan 2018 (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.
Currently chest X-ray (CXR) is the modality used to assess for pneumothorax after transthoracic lung biopsy at the Ottawa Hospital. Recently bedside Ultrasound (US) has become a useful rapid imaging modality to assess chest for pneumothorax in emergency rooms with reported sensitivity, specificity and diagnostic accuracy were 88%, 97% and 97%, respectively (ref. 2).
Our team will be comparing the diagnostic accuracy of US to CXR in diagnoses of pneumothorax post transthoracic lung biopsy.
The purpose of the study is to compare the diagnostic accuracy of US to CXR post-biopsy to confirm the presence of a pneumothorax.
Detailed description
Hypothesis:
US have sensitivity and specificity equal or better than CXR to exclude pneumothorax after transthoracic lung biopsy.
Clinical relevance:
Pneumothorax is a well-known complication of image-guided transthoracic biopsy of lung lesions. The incidence of pneumothorax in patients undergoing TTNB has been reported to be from 9% to 54% (ref. 3). Most of the time, the pneumothorax is small and requires no further intervention other than observation and a repeat CXR to ensure stability or resolution of the pneumothorax. In small group of patients with detected pneumothorax after biopsy, the pneumothorax is either large or becomes larger (more than 2 cm width at the level of the hilum) during observation. In these cases, a small pleural drainage catheter will be inserted to prevent the lung from collapsing. The catheter will be removed in 2 days. Detection of pneumothorax post biopsy is important to prevent possible lung collapse after discharge and currently is done by obtaining a CXR, 30 minutes after the biopsy.
Obtaining a CXR, requires moving the patient on stretcher to the X-ray room, bringing the patient to upright position, patient holds breath. An X-ray technologist obtains the CXR which will be reviewed by a Radiologist when it becomes available on work station. Then the Radiologist revisits the patient and orders the discharge.
Detection of pneumothorax by US is feasible and compare to current practice with CXR, is faster and do not need moving and repositioning the patient, therefore, more convenient. It can be easily performed at the time of clinical assessment prior to discharge.
Study design/ Methodology:
- All patients coming for lung biopsy will be invited to participate in this study. Information about the one additional US at the time of their biopsy and routine CXR will be explained to the patient by either thoracic radiology fellow or staff radiologist.
- For those who agree to participate, informed Consent will be obtained by the same people mentioned above.
- There will be no change in clinical assessment or decision to discharge the patient after biopsy.
- US will be performed by a trained staff radiologist or thoracic fellow.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Imaging | Experimental | Device: Ultrasound (US) ImagingA Single Ultrasound Imaging to diagnose of pneumothorax post transthoracic lung biopsy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are booked and coming for image-guided transthoracic biopsy of a lung lesion to the Ottawa Hospital, General Campus, will be consented and those who agree to added US will be included
Key exclusion criteria (1 listed)
- Other patients.
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 |
|---|---|---|
| Ultrasound (US) ImagingUltrasound (US) Imaging will be compared to the chest X-ray for diagnostic accuracy (sensitivity and specificity) in diagnoses of pneumothorax post transthoracic lung biopsy | Device | Ultrasound Imaging |
Primary outcome
Diagnostic Accuracy
Time frame: One year
To determine if the sensitivity and specificity of US is equal or better than routine CXR in diagnosing pneumothorax post lung biopsy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 26407979Quick JA, Uhlich RM, Ahmad S, Barnes SL, Coughenour JP. In-flight ultrasound identification of pneumothorax. Emerg Radiol. 2016 Feb;23(1):3-7. doi: 10.1007/s10140-015-1348-z. Epub 2015 Sep 25.
- 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 24672704Boskovic T, Stanic J, Pena-Karan S, Zarogoulidis P, Drevelegas K, Katsikogiannis N, Machairiotis N, Mpakas A, Tsakiridis K, Kesisis G, Tsiouda T, Kougioumtzi I, Arikas S, Zarogoulidis K. Pneumothorax after transthoracic needle biopsy of lung lesions under CT guidance. J Thorac Dis. 2014 Mar;6 Suppl 1(Suppl 1):S99-S107. doi: 10.3978/j.issn.2072-1439.2013.12.08.
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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.
Betty Anne Schwarz, Ph.D. study director
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound (US) Imaging in people with Pneumothorax, run by Ottawa Hospital Research Institute 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 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: finished, as of the sponsor's last update on 5 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic Accuracy (time frame: One year). 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 NCT03397290, which also lists 3 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 5 Sep 2021.