Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT02453724

Conditions

Pulmonary Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Observation for safety

Study Details

Brief 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

Study ID

NCT02453724

Start date

Aug, 2015

Status verified date

Mar, 2016

Completion date

Aug, 2017

Anticipated

Primary completion date

Aug, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All patients greater than 18 years of age scheduled to receive chest tomography scans for pulmonary embolus.

Exclusion Criteria:

  • None.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Micro or macroscopic lung parenchymal hemorrhage [ Time Frame: At enrollment ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 20114

Contacts

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 18, 2016

Last verified

Mar, 2016

Keywords

  • Ultrasonography
  • Lung
  • Hemorrhage
  • Point of care ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2016-03-18.