NCT02619591

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 7, 2016

Completed
Last Updated

November 7, 2016

Status Verified

December 1, 2015

Enrollment Period

2.5 years

First QC Date

November 23, 2015

Results QC Date

December 7, 2015

Last Update Submit

September 19, 2016

Conditions

Pneumothorax

Outcome Measures

Primary Outcomes (1)

  • Pneumothorax (Positive or Negative)

    The presence of a pneumothorax at the time of the ultrasound

    up to 20 minutes

Study Arms (2)

Ultrasound Imaging - Single View

ACTIVE COMPARATOR

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

Other: Ultrasound Imaging

Ultrasound Imaging - Multiple Views

EXPERIMENTAL

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

Other: Ultrasound Imaging

Interventions

Ultrasound ImagingOTHER

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

Ultrasound Imaging - Multiple ViewsUltrasound Imaging - Single View

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had trauma and are receiving a chest CT.

You may not qualify if:

  • Clinically Unstable
  • Clinical care prevented ultrasound
  • Patient with a chest tube in place
  • Pregnant Women
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumothorax

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Results Point of Contact

Title
Executive Vice Chairman
Organization
UMASS Memorial Department of Emergency Medicine
Romolo.Gaspari@umassmemorial.org
508-421-1400

Study Officials

  • Romolo Gaspari, MD

    UMASS Memorial

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Vice Chairman

Study Record Dates

First Submitted

November 23, 2015

First Posted

December 2, 2015

Study Start

September 1, 2011

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

November 7, 2016

Results First Posted

November 7, 2016

Record last verified: 2015-12