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Lung Ultrasound Safety in Humans

NCT02453724 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2016-03-18

No results posted yet for this study

Summary

The purpose of this study is to investigate if diagnostic ultrasound as it is routinely performed in humans causes lung hemorrhage significant enough to appear on thoracic CT. The investigators' hypothesis is that diagnostic lung ultrasound will not cause lung hemorrhage in humans. Damage to the lung in animal models has been shown to be mechanical rather than thermal in nature and evidence suggests that this injury is likely not from inertial cavitation but from alveolar resonance. Models of the alveolar resonance theory predict that hemorrhage should not happen in adult human lungs if the ultrasound frequency is higher than 1.69 MHz and mechanical index (MI) is less than 1.9 which is maintained with standard scanning protocol for thoracic ultrasound. A previous human study showed no gross macroscopic lung hemorrhage in patients undergoing transesophageal echocardiography with pressures of 2.4 MPa and MI 1.3 with exposure durations ranging 7-68 minutes.

The investigators propose to perform a routine lung ultrasound exam on patients who are scheduled to undergo chest computed tomography evaluation for pulmonary embolus as part of their routine care. The ultrasound will be performed immediately prior to CT imaging and markers will be placed on the patients chest to ensure the correct lung tissue is being evaluated. There will be two sham markers so the radiologist will be blinded to which tissue had ultrasound applied and which did not. The CT scan will then be evaluated per routine and also to see if there are signs of microscopic or macroscopic hemorrhage under the skin markers.

Conditions

  • Pulmonary Hemorrhage

Interventions

DEVICE

Observation for safety

The investigators will perform the routine lung exam used in emergency department evaluations for shortness of breath in patients scheduled for computed tomography. The investigators will observe if there are any parenchymal changes noted on the chest tomography scan.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Vicki E Noble, MD · Massachusetts General Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02453724 on ClinicalTrials.gov