Pulmonary HemorrhageNCT02453724
Lung Ultrasound Safety in Humans
An observational study of Pulmonary Hemorrhage, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hemorrhage
- What is being tested?
- Observation for safety
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All emergency department patients greater than 18 years of age
Who may be able to join
- All patients greater than 18 years of age scheduled to receive chest tomography scans for pulmonary embolus.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 20114
Vicki Noble, MD, 617-726-5655, vnoble@partners.org
About this study
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.
Read the detailed description
This is a prospective, observational cohort study of emergency department patients designed to assess for radiographic changes suggestive of lung hemorrhage after thoracic ultrasound.
The investigators will only approach patients scheduled for CT scan as part of their routine care in the emergency department for enrollment. Only patients > 18 years old. Patients who are not english speaking will only be consented if there is a medical interpreter immediately available who can be approached for informed consent.
Patients who have given informed consent will have a lung ultrasound performed by a study physician immediately prior to CT scan - after the patient has been transported to the ED radiology area but before the CT scan is performed. The lung ultrasound will be performed using a low frequency probe (2-5 MHz). Of the four standard positions used in lung ultrasonography (Zone 1, 4, 5, 8; see Image 1 below), study ultrasonography will be performed on only two.
The two positions selected for use will be chosen immediately prior to ultrasound performance by the performing physician using a simple binary random number generator for each lung. This will ensure that one zone is subjected to ultrasound on each lung. A small radio-opaque button will be placed overlying all four zones (i.e., those exposed and those not exposed) in the standard position of the ultrasound footprint (ie where the ultrasound was or would have been performed) and then the patient will undergo the CT scan according to standard radiology department protocols.
The CT scan will then be reviewed for signs of alveolar hemorrhage in the lung tissue immediately adjacent to the radio-opaque button. Radiologists will be blinded as to which buttons abut zones exposed to ultrasound or not exposed. Any findings will be immediately reported to the patient's care team and the patient and standard protocols for treatment and observation will be followed.
The investigators have calculated the need to enroll 200 patients to observe a 7% range above and below previously published numbers of incidental findings on chest CT scan.
- Conditions
- Pulmonary Hemorrhage
- Being tested
- Observation for safety
- Keywords
- Ultrasonography, Lung, Hemorrhage, Point of care ultrasound
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation for safetyDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HemorrhageStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicki Noble, MD, Massachusetts General Hospital
- Investigators
- Vicki E Noble, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453724
- Sponsor's protocol ID
- 2013P002671
- Status last verified
- Mar 2016
- First submitted
- 21 May 2015
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17112965Miller 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.
PubMed 22698500Jabaraj 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
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.
PubMed 9487470Bruzzi 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.
PubMed 16418239Child 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.
PubMed 2095012
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Safety in Humans
- ClinicalTrials.gov ID
- NCT02453724
- Acronym / sponsor ID
- 2013P002671
- Conditions
- Pulmonary Hemorrhage
- Keywords
- Ultrasonography, Lung, Hemorrhage, Point of care ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, observational cohort study of emergency department patients designed to assess for radiographic changes suggestive of lung hemorrhage after thoracic ultrasound.
The investigators will only approach patients scheduled for CT scan as part of their routine care in the emergency department for enrollment. Only patients > 18 years old. Patients who are not english speaking will only be consented if there is a medical interpreter immediately available who can be approached for informed consent.
Patients who have given informed consent will have a lung ultrasound performed by a study physician immediately prior to CT scan - after the patient has been transported to the ED radiology area but before the CT scan is performed. The lung ultrasound will be performed using a low frequency probe (2-5 MHz). Of the four standard positions used in lung ultrasonography (Zone 1, 4, 5, 8; see Image 1 below), study ultrasonography will be performed on only two.
The two positions selected for use will be chosen immediately prior to ultrasound performance by the performing physician using a simple binary random number generator for each lung. This will ensure that one zone is subjected to ultrasound on each lung. A small radio-opaque button will be placed overlying all four zones (i.e., those exposed and those not exposed) in the standard position of the ultrasound footprint (ie where the ultrasound was or would have been performed) and then the patient will undergo the CT scan according to standard radiology department protocols.
The CT scan will then be reviewed for signs of alveolar hemorrhage in the lung tissue immediately adjacent to the radio-opaque button. Radiologists will be blinded as to which buttons abut zones exposed to ultrasound or not exposed. Any findings will be immediately reported to the patient's care team and the patient and standard protocols for treatment and observation will be followed.
The investigators have calculated the need to enroll 200 patients to observe a 7% range above and below previously published numbers of incidental findings on chest CT scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All emergency department patients greater than 18 years of age
Key inclusion criteria (1 listed)
- All patients greater than 18 years of age scheduled to receive chest tomography scans for pulmonary embolus.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation for safetyThe 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. | Device | – |
Primary outcome
Micro or macroscopic lung parenchymal hemorrhage
Time frame: At enrollment
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- Background: PubMed 17112965O'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.
- Background: PubMed 22698500Miller 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.
- BackgroundJabaraj 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: PubMed 9487470Meltzer 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.
- Background: PubMed 16418239Bruzzi 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.
- Results publication: PubMed 2095012Child 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicki E Noble, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hemorrhage, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vicki E Noble, MD (617-726-5655, vnoble@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Micro or macroscopic lung parenchymal hemorrhage (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02453724, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2016.