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Clinical Trials/NCT02619591
NCT02619591
Completed
Not Applicable

Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax

University of Massachusetts, Worcester0 sites260 target enrollmentSeptember 2011
ConditionsPneumothorax

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumothorax
Sponsor
University of Massachusetts, Worcester
Enrollment
260
Primary Endpoint
Pneumothorax (Positive or Negative)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
June 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Principal Investigator
Principal Investigator

Romolo Gaspari

Executive Vice Chairman

University of Massachusetts, Worcester

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

Outcomes

Primary Outcomes

Pneumothorax (Positive or Negative)

Time Frame: up to 20 minutes

The presence of a pneumothorax at the time of the ultrasound

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