PneumoniaNCT02638649
Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
An observational study of Pneumonia and Pulmonary Edema, run by Yale University at 2 sites in United States.
Trial summary
This is a pilot observational feasibility study of the ability of paramedics to assess thoracic ultrasound findings in the prehospital environment. The primary goal of the study is to determine whether paramedics are able to accurately assess for sonographic B-lines in patients with undifferentiated shortness of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pulmonary Edema, Dyspnea
- What is being tested?
- Lung ultrasound and ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to 15 Sep 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with dyspnea
Who may be able to join
- Dyspnea and any of the following:
- Respiratory rate > 20
- Room air oxygen saturation < 92%
- Accessory muscle use, tripod position, nasal flaring
- Exam with evidence of rales/rhonchi or wheezing
- In acute respiratory distress on paramedic evaluation
- Any patient in acute respiratory distress with
Who cannot join
- Trauma
- Burns
- Pregnancy
- Kussmaul respirations from metabolic acidosis
- Cheyne-stokes from increased ICP (intracranial pressure), heart failure or CVA
- Drowning
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale-New Haven Hospital-Saint Raphael Campus
New Haven, Connecticut, 06517
Yale New Haven Hospital
New Haven, Connecticut, 06519-1362
About this study
This is a pilot observational feasibility study of the ability of paramedics to assess thoracic ultrasound findings in the prehospital environment. The primary goal of the study is to determine whether paramedics are able to accurately assess for sonographic B-lines in patients with undifferentiated shortness of breath at least 80% of the time in the prehospital environment using a portable ultrasound (U/S) device.
Read the detailed description
In the first phase of the study, a cohort of senior and supervisory paramedics will be recruited into the study. These paramedics would undergo didactic and hands-on training to learn how to operate the U/S machine, and obtain and interpret basic U/S images. The paramedics will then participate in video review sessions and spend time in the emergency department (ED) with the U/S team to get hands-on experience with patients. In the second phase of the study, paramedics will be staffing ambulances or fly cars in and around the greater New Haven region and will respond to dyspnea calls. At each call, the paramedic will initially evaluate the patient clinically conducting a standard history and physical exam. The paramedic will then use the portable U/S machine to look for the presence of either unilateral or bilateral B-lines indicating possible pneumonia (in the case of unilateral B-lines) or pulmonary edema (in the case of bilateral B-lines). The paramedic will then document the presence or absence of B-lines for each lung on the prehospital study sheet. The paramedic will then use the U/S to evaluate for the presence of pleural effusions, lung sliding and pericardial effusion.
- Conditions
- Pneumonia, Pulmonary Edema, Dyspnea
- Being tested
- Lung ultrasound, ultrasound
- Keywords
- lung ultrasound
- Medical subject headings
- Pneumonia, Pulmonary Edema, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundProcedure or surgery
At each call, the paramedic will initially evaluate the patient clinically conducting a standard history and physical exam. The paramedic will then use the portable U/S machine to look for the presence of either unilateral or bilateral B-lines indicating possible pneumonia (in the case of unilateral B-lines) or pulmonary edema (in the case of bilateral B-lines). The paramedic will then document the presence or absence of B-lines for each lung on the prehospital study sheet. The paramedic will then use the U/S to evaluate for the presence of pleural effusions, lung sliding and pericardial effusion.
ultrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| subjects who call 911 for dyspnea | All subjects who call 9-1-1 for difficulty breathing will have the potential to be enrolled in the study. Receives: Procedure: Lung ultrasound; Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Paramedics' assessments of ultrasound for unilateral or bilateral B-lines
The paramedic will use the portable U/S machine to look for the presence of either unilateral/bilateral B-lines indicating possible pneumonia (unilateral B-lines) or pulmonary edema (bilateral B-lines). The paramedic will document the presence or absence of B-lines for each lung on the prehospital study sheet. The attending ED physician will be notified of the enrolled patient and, blinded to the paramedic's interpretation, will then conduct the same U/S study and document their findings and the final diagnosis of the patient using the patient's name, birthdate and MRN (Medical Record Number) on the ED study sheet. An U/S expert, blinded to the patient's diagnosis, the U/S operator, and confirmatory imaging, will review the recorded images obtained in the prehospital setting. The expert's interpretation of the images will be confirmed by a second expert for at least 15 % of the cases. The goal is 80% accuracy. The accuracy will be evaluated up to 12 months after the U/S is taken.
Measured: up to 12 months
Secondary outcomes (1)
Accuracy of Paramedics' assessments of ultrasound for interpretation of lung sliding, pleural effusions, and pericardial effusions.
The paramedic will use the U/S to evaluate for the presence of pleural effusions, lung sliding and pericardial effusion. The attending ED physician will be notified of the enrolled patient and, without knowing the paramedic's interpretation, will then conduct the same U/S study and document his or her findings and the final diagnosis of the patient using the patient's name, birthdate and MRN on the ED study sheet. An U/S expert, blinded to the patient's diagnosis, the U/S operator, and confirmatory imaging, will review the recorded images obtained in the prehospital setting. The expert's interpretation of the images will be confirmed by a second expert for at least 15 % of the cases. The goal is 80% accuracy. The accuracy will be evaluated up to 12 months after the ultrasound has been taken.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startSep 2016
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David C Cone, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638649
- Sponsor's protocol ID
- 1511016808
- Status last verified
- Mar 2020
- First submitted
- 11 Dec 2015
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
- ClinicalTrials.gov ID
- NCT02638649
- Acronym / sponsor ID
- 1511016808
- Conditions
- Pneumonia, Pulmonary Edema, Dyspnea
- Keywords
- lung ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 23 Dec 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.
This is a pilot observational feasibility study of the ability of paramedics to assess thoracic ultrasound findings in the prehospital environment. The primary goal of the study is to determine whether paramedics are able to accurately assess for sonographic B-lines in patients with undifferentiated shortness of breath at least 80% of the time in the prehospital environment using a portable ultrasound (U/S) device.
Detailed description
In the first phase of the study, a cohort of senior and supervisory paramedics will be recruited into the study. These paramedics would undergo didactic and hands-on training to learn how to operate the U/S machine, and obtain and interpret basic U/S images. The paramedics will then participate in video review sessions and spend time in the emergency department (ED) with the U/S team to get hands-on experience with patients. In the second phase of the study, paramedics will be staffing ambulances or fly cars in and around the greater New Haven region and will respond to dyspnea calls. At each call, the paramedic will initially evaluate the patient clinically conducting a standard history and physical exam. The paramedic will then use the portable U/S machine to look for the presence of either unilateral or bilateral B-lines indicating possible pneumonia (in the case of unilateral B-lines) or pulmonary edema (in the case of bilateral B-lines). The paramedic will then document the presence or absence of B-lines for each lung on the prehospital study sheet. The paramedic will then use the U/S to evaluate for the presence of pleural effusions, lung sliding and pericardial effusion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects who call 911 for dyspnea | – | Procedure: Lung ultrasound, Device: ultrasoundAll subjects who call 9-1-1 for difficulty breathing will have the potential to be enrolled in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with dyspnea
Key inclusion criteria (7 listed)
- Dyspnea and any of the following:
- Respiratory rate > 20
- Room air oxygen saturation < 92%
- Accessory muscle use, tripod position, nasal flaring
- Exam with evidence of rales/rhonchi or wheezing
Key exclusion criteria (6 listed)
- Trauma
- Burns
- Pregnancy
- Kussmaul respirations from metabolic acidosis
- Cheyne-stokes from increased ICP (intracranial pressure), heart failure or CVA
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 |
|---|---|---|
| Lung ultrasoundAt each call, the paramedic will initially evaluate the patient clinically conducting a standard history and physical exam. The paramedic will then use the portable U/S machine to look for the presence of either unilateral or bilateral B-lines indicating possible pneumonia (in the case of unilateral B-lines) or pulmonary edema (in the case of bilateral B-lines). The paramedic will then document the presence or absence of B-lines for each lung on the prehospital study sheet. The paramedic will then use the U/S to evaluate for the presence of pleural effusions, lung sliding and pericardial effusion. | Procedure or surgery | subjects who call 911 for dyspnea |
| ultrasound | Device | subjects who call 911 for dyspnea |
Primary outcome
Accuracy of Paramedics' assessments of ultrasound for unilateral or bilateral B-lines
Time frame: up to 12 months
The paramedic will use the portable U/S machine to look for the presence of either unilateral/bilateral B-lines indicating possible pneumonia (unilateral B-lines) or pulmonary edema (bilateral B-lines). The paramedic will document the presence or absence of B-lines for each lung on the prehospital study sheet. The attending ED physician will be notified of the enrolled patient and, blinded to the paramedic's interpretation, will then conduct the same U/S study and document their findings and the final diagnosis of the patient using the patient's name, birthdate and MRN (Medical Record Number) on the ED study sheet. An U/S expert, blinded to the patient's diagnosis, the U/S operator, and confirmatory imaging, will review the recorded images obtained in the prehospital setting. The expert's interpretation of the images will be confirmed by a second expert for at least 15 % of the cases. The goal is 80% accuracy. The accuracy will be evaluated up to 12 months after the U/S is taken.
1 secondary outcome
Accuracy of Paramedics' assessments of ultrasound for interpretation of lung sliding, pleural effusions, and pericardial effusions.
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: No
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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.
David C Cone, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Pulmonary Edema, run by Yale University at 2 sites 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Paramedics' assessments of ultrasound for unilateral or bilateral B-lines (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2020.