Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax
Primary Purpose
Pneumothorax
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Pneumothorax
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ultrasound Imaging - Single View
Ultrasound Imaging - Multiple Views
Arm Description
Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient
Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient
Outcomes
Primary Outcome Measures
Pneumothorax (Positive or Negative)
The presence of a pneumothorax at the time of the ultrasound
Secondary Outcome Measures
Full Information
NCT ID
NCT02619591
First Posted
November 23, 2015
Last Updated
September 19, 2016
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT02619591
Brief Title
Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax
Official Title
Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound Imaging - Single View
Arm Type
Active Comparator
Arm Description
Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient
Arm Title
Ultrasound Imaging - Multiple Views
Arm Type
Experimental
Arm Description
Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient
Intervention Type
Other
Intervention Name(s)
Ultrasound Imaging
Intervention Description
views of a hemithorax was obtained using the Zonare Ultrasound machine.
Primary Outcome Measure Information:
Title
Pneumothorax (Positive or Negative)
Description
The presence of a pneumothorax at the time of the ultrasound
Time Frame
up to 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romolo Gaspari, MD
Organizational Affiliation
UMASS Memorial
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax
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