Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax

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.

Study Overview

• Status: Completed
• Conditions: Pneumothorax
• Intervention / Treatment: Other: Ultrasound Imaging

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 Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound Imaging - Single View; Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient	Other: Ultrasound Imaging; views of a hemithorax was obtained using the Zonare Ultrasound machine.
Experimental: Ultrasound Imaging - Multiple Views; Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient	Other: Ultrasound Imaging; views of a hemithorax was obtained using the Zonare Ultrasound machine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumothorax (Positive or Negative)	The presence of a pneumothorax at the time of the ultrasound	up to 20 minutes

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Principal Investigator: Romolo Gaspari, MD, UMass Memorial

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: Umass

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No