Pneumothorax
Conditions
Brief 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.
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.
Interventions
OTHERUltrasound Imaging
views of a hemithorax was obtained using the Zonare Ultrasound machine.
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who had trauma and are receiving a chest CT.
Exclusion criteria
* Clinically Unstable * Clinical care prevented ultrasound * Patient with a chest tube in place * Pregnant Women * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pneumothorax (Positive or Negative) | up to 20 minutes | The presence of a pneumothorax at the time of the ultrasound |
Participant flow
Recruitment details
Patients with chest trauma presenting to the emergency department who were going to get a CT of the chest were eligible
Pre-assignment details
Exclusions were patients who had recieved a chest tube already, or those with known pneumothoraces.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 139 |
| Ultrasound Imaging - Multiple Views 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. | 121 |
| Total | 260 |
Baseline characteristics
| Characteristic | Ultrasound Imaging - Multiple Views | Total | Ultrasound Imaging - Single View |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 12 | 45 years STANDARD_DEVIATION 11 | 44 years STANDARD_DEVIATION 13 |
| Blunt Trauma Blunt Truama | 115 participants | 248 participants | 133 participants |
| Blunt Trauma Penetrating Trauma | 6 participants | 12 participants | 6 participants |
| Region of Enrollment United States | 121 participants | 260 participants | 139 participants |
| Sex: Female, Male Female | 35 Participants | 74 Participants | 39 Participants |
| Sex: Female, Male Male | 86 Participants | 186 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 139 | 0 / 121 |
| serious Total, serious adverse events | 0 / 139 | 0 / 121 |
Outcome results
Primary
Pneumothorax (Positive or Negative)
The presence of a pneumothorax at the time of the ultrasound
Time frame: up to 20 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device - Ultrasound Imaging - Single View | Pneumothorax (Positive or Negative) | 17 participants |
| Device - Ultrasound Imaging - Multiple Views | Pneumothorax (Positive or Negative) | 21 participants |