Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax

NCT ID: NCT02619591

Last Updated: 2016-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-06-30

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.

Conditions

Pneumothorax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Ultrasound Imaging - Single View

Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient

Group Type: ACTIVE_COMPARATOR

Ultrasound Imaging

Intervention Type: OTHER

views of a hemithorax was obtained using the Zonare Ultrasound machine.

Ultrasound Imaging - Multiple Views

Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient

Group Type: EXPERIMENTAL

Ultrasound Imaging

Intervention Type: OTHER

views of a hemithorax was obtained using the Zonare Ultrasound machine.

Interventions

Ultrasound Imaging

views of a hemithorax was obtained using the Zonare Ultrasound machine.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Romolo Gaspari

Executive Vice Chairman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Romolo Gaspari, MD

Role: PRINCIPAL_INVESTIGATOR

UMASS Memorial

Other Identifiers

Umass

Identifier Type: -

Identifier Source: org_study_id