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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Imaging - Single View | Active Comparator | Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient |
|
| Ultrasound Imaging - Multiple Views | Experimental | Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Imaging | Other | views of a hemithorax was obtained using the Zonare Ultrasound machine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pneumothorax (Positive or Negative) | The presence of a pneumothorax at the time of the ultrasound | up to 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Romolo Gaspari, MD | UMASS Memorial | Principal Investigator |
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Exclusions were patients who had recieved a chest tube already, or those with known pneumothoraces.
Patients with chest trauma presenting to the emergency department who were going to get a CT of the chest were eligible
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| ID | Title | Description |
|---|---|---|
| FG000 | "Device" - Ultrasound Imaging - Single View | Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine. |
| FG001 | "Device" - Ultrasound Imaging - Multiple Views | Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound Imaging - Single View | Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine. |
| BG001 | Ultrasound Imaging - Multiple Views |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pneumothorax (Positive or Negative) | The presence of a pneumothorax at the time of the ultrasound | Posted | Number | participants | up to 20 minutes |
|
1 week
Truama patients were followed for their admission time
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | "Device" - Ultrasound Imaging - Single View | Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Vice Chairman | UMASS Memorial Department of Emergency Medicine | 508-421-1400 | Romolo.Gaspari@umassmemorial.org |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Blunt Trauma | Number | participants |
|
|
|
| 0 |
| 139 |
| 0 |
| 139 |
| EG001 | "Device" - Ultrasound Imaging - Multiple Views | Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine. | 0 | 121 | 0 | 121 |
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| D055585 |
| Physical Phenomena |