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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
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumothorax

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 23, 2015
    Last Updated
    September 19, 2016
    Sponsor
    University of Massachusetts, Worcester
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    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

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    Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax

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