Lung Ultrasound Safety in Humans

NCT02453724 | Unknown

• 1 other identifier: 2013P002671
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Ultrasonography; Lung; Hemorrhage; Point of care ultrasound

Outcome Measures

Primary Outcomes (1)

• Micro or macroscopic lung parenchymal hemorrhage

  The investigators will perform the ultrasound just prior to chest computed tomography enrollment so that there is minimal time delay between the ultrasound performance and assessment of the lung parenchyma.

  At enrollment

Interventions

Observation for safety DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All emergency department patients greater than 18 years of age

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 20114, United States

RECRUITING

Related Publications (6)

• O'Brien WD Jr, Yang Y, Simpson DG, Frizzell LA, Miller RJ, Blue JP Jr, Zachary JF. Threshold estimation of ultrasound-induced lung hemorrhage in adult rabbits and comparison of thresholds in mice, rats, rabbits and pigs. Ultrasound Med Biol. 2006 Nov;32(11):1793-804. doi: 10.1016/j.ultrasmedbio.2006.03.011.

  PMID: 17112965 BACKGROUND

• Miller DL. Induction of pulmonary hemorrhage in rats during diagnostic ultrasound. Ultrasound Med Biol. 2012 Aug;38(8):1476-82. doi: 10.1016/j.ultrasmedbio.2012.04.004. Epub 2012 Jun 12.

  PMID: 22698500 BACKGROUND

• Jabaraj DJ, Jaafar MS. Theoretical calculation of resonant frequencies of the human alveolar wall and its implications in ultrasound-induced lung hemorrhage. Int J Bioscience Biochem Bioinformatics. 2013;3(1):5-9

  BACKGROUND

• Meltzer RS, Adsumelli R, Risher WH, Hicks GL Jr, Stern DH, Shah PM, Wojtczak JA, Lustik SJ, Gayeski TE, Shapiro JR, Carstensen EL. Lack of lung hemorrhage in humans after intraoperative transesophageal echocardiography with ultrasound exposure conditions similar to those causing lung hemorrhage in laboratory animals. J Am Soc Echocardiogr. 1998 Jan;11(1):57-60. doi: 10.1016/s0894-7317(98)70120-8.

  PMID: 9487470 BACKGROUND

• Bruzzi JF, Remy-Jardin M, Delhaye D, Teisseire A, Khalil C, Remy J. Multi-detector row CT of hemoptysis. Radiographics. 2006 Jan-Feb;26(1):3-22. doi: 10.1148/rg.261045726.

  PMID: 16418239 BACKGROUND

• Child SZ, Hartman CL, Schery LA, Carstensen EL. Lung damage from exposure to pulsed ultrasound. Ultrasound Med Biol. 1990;16(8):817-25. doi: 10.1016/0301-5629(90)90046-f.

  PMID: 2095012 RESULT

MeSH Terms

Conditions

Hemorrhage

Interventions

Observation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Vicki E Noble, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicki E Noble, MD

CONTACT

617-726-5655; vnoble@partners.org

John T Nagurney, MD

CONTACT

617-726-7623; jnagurney@partners.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Emergency Ultrasound

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 25, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 18, 2016

Record last verified: 2016-03

Locations

US (1)