PneumothoraxNCT02619591
Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax
A study testing Ultrasound Imaging in people with Pneumothorax, run by University of Massachusetts, Worcester.
Trial summary
Patients with chest trauma undergo ultrasound to detect a collapsed lung. Two techniques have been described. A single view for each hemi-thorax, and multiple views for each hemithorax. The investigators are comparing these two techniques in a randomized prospective trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Ultrasound Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients who had trauma and are receiving a chest CT.
Who cannot join
- Clinically Unstable
- Clinical care prevented ultrasound
- Patient with a chest tube in place
- Pregnant Women
- Prisoners
About this study
Patients with chest trauma undergo ultrasound to detect a collapsed lung. Two techniques have been described. A single view for each hemi-thorax, and multiple views for each hemithorax. The investigators are comparing these two techniques in a randomized prospective trial.
Read the detailed description
This is a randomized, prospective blinded study on trauma patients arriving to an emergency department.
Study Setting and Population This study will be conducted on the University Campus of the University of Massachusetts Medical Center, which is an urban academic emergency department that sees 80,000 patients annually and has a dedicated Level I trauma service that is staffed by trauma surgery and emergency medicine. Adult patients with acute traumatic injury who are undergoing a CT scan of the chest are eligible for enrollment.
Study Protocol Trauma patients are enrolled as they arrived to the emergency department. The investigators will include any trauma patient aged 18 and over. The investigtors will exclude any patient who was too unstable and required clinical care that prevented performing a chest wall ultrasound, patients with a chest tube in place prior to arrival, pregnant women, and prisoners. Imaging decisions on trauma patients will be made early on in their evaluation. The patient will be assigned using a pre-determined randomization scheme to a single view or four views of each hemi-thorax prior to any imaging being done. Ultrasounds will be performed and interpreted by credentialed physicians using a 7.5Mhz linear array transducer on a portable ultrasound machine (Zonare z.one ultra) with digital clips recorded for later review. When the investigators obtain a single view of each hemi-thorax, the probe will be placed in a longitudinal orientation on the midclavicular line in the third intercostal space. When the investigators obtain four views of each hemi-thorax, the first image location will be the same as in the single view and then the probe will be moved inferiorly and laterally to obtain the additional three images. Immediately following the ultrasound examination, the patient will be transported to the CT scanner for further imaging.
The goal of this study is to determine if a single view of each hemi-thorax can identify a pneumothorax or if additional images should be included. The primary study endpoint is the presence of a pneumothorax on ultrasound.
- Conditions
- Pneumothorax
- Being tested
- Ultrasound Imaging
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ImagingOther
views of a hemithorax was obtained using the Zonare Ultrasound machine.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Imaging - Single View | Active comparator | Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient Receives: Other: Ultrasound Imaging |
| Ultrasound Imaging - Multiple Views | Experimental | Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient Receives: Other: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumothorax (Positive or Negative)
The presence of a pneumothorax at the time of the ultrasound
Measured: up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startSep 2011
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romolo Gaspari, University of Massachusetts, Worcester
- Investigators
- Romolo Gaspari, MD, Principal investigator, UMASS Memorial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619591
- Sponsor's protocol ID
- Umass
- Status last verified
- Dec 2015
- First submitted
- 23 Nov 2015
- Last updated
- 7 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax
- ClinicalTrials.gov ID
- NCT02619591
- Acronym / sponsor ID
- Umass
- Conditions
- Pneumothorax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Posted 7 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with chest trauma undergo ultrasound to detect a collapsed lung. Two techniques have been described. A single view for each hemi-thorax, and multiple views for each hemithorax. The investigators are comparing these two techniques in a randomized prospective trial.
Detailed description
This is a randomized, prospective blinded study on trauma patients arriving to an emergency department.
Study Setting and Population This study will be conducted on the University Campus of the University of Massachusetts Medical Center, which is an urban academic emergency department that sees 80,000 patients annually and has a dedicated Level I trauma service that is staffed by trauma surgery and emergency medicine. Adult patients with acute traumatic injury who are undergoing a CT scan of the chest are eligible for enrollment.
Study Protocol Trauma patients are enrolled as they arrived to the emergency department. The investigators will include any trauma patient aged 18 and over. The investigtors will exclude any patient who was too unstable and required clinical care that prevented performing a chest wall ultrasound, patients with a chest tube in place prior to arrival, pregnant women, and prisoners. Imaging decisions on trauma patients will be made early on in their evaluation. The patient will be assigned using a pre-determined randomization scheme to a single view or four views of each hemi-thorax prior to any imaging being done. Ultrasounds will be performed and interpreted by credentialed physicians using a 7.5Mhz linear array transducer on a portable ultrasound machine (Zonare z.one ultra) with digital clips recorded for later review. When the investigators obtain a single view of each hemi-thorax, the probe will be placed in a longitudinal orientation on the midclavicular line in the third intercostal space. When the investigators obtain four views of each hemi-thorax, the first image location will be the same as in the single view and then the probe will be moved inferiorly and laterally to obtain the additional three images. Immediately following the ultrasound examination, the patient will be transported to the CT scanner for further imaging.
The goal of this study is to determine if a single view of each hemi-thorax can identify a pneumothorax or if additional images should be included. The primary study endpoint is the presence of a pneumothorax on ultrasound.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Imaging - Single View | Active comparator | Other: Ultrasound ImagingUltrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient |
| Ultrasound Imaging - Multiple Views | Experimental | Other: Ultrasound ImagingUltrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had trauma and are receiving a chest CT.
Key exclusion criteria (5 listed)
- Clinically Unstable
- Clinical care prevented ultrasound
- Patient with a chest tube in place
- Pregnant Women
- Prisoners
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 Imagingviews of a hemithorax was obtained using the Zonare Ultrasound machine. | Other | Ultrasound Imaging - Multiple Views, Ultrasound Imaging - Single View |
Primary outcome
Pneumothorax (Positive or Negative)
Time frame: up to 20 minutes
The presence of a pneumothorax at the time of the ultrasound
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Romolo Gaspari, MD principal investigator
UMASS Memorial
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Imaging in people with Pneumothorax, run by University of Massachusetts, Worcester.
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 5 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 7 Nov 2016. 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?
Yes. Results are posted in the registry (first posted 7 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pneumothorax (Positive or Negative) (time frame: up to 20 minutes). 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 Nov 2016.