Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax

Pneumothorax Clinical Trial

Official title:

Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619591
• Other study ID #: Umass
• Status: Completed
• Phase: N/A
• First received: November 23, 2015
• Last updated: November 30, 2015
• Start date: September 2011
• Est. completion date: June 2014

Study information

• Verified date: November 2015
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 teh 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Device:
• Ultrasound Imaging Technique - Single View
A single view of a hemithorax was obtained using the Zonare Ultrasound machine.
• Ultrasound Imaging Technique - Multiple Views
Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumothorax (positive or negative)	The presence of a pneumothorax at the time of the ultrasound	up to 20 minutes	No