Clinical trial NCT02638649: Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Official title: Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Pulmonary Edema
Dyspnea
Keywords: lung ultrasound
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with dyspnea

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

* Trauma
* Burns
* Pregnancy
* Kussmaul respirations from metabolic acidosis
* Cheyne-stokes from increased ICP (intracranial pressure), heart failure or CVA
* Drowning

Primary outcomes:
measure: Accuracy of Paramedics' assessments of ultrasound for unilateral or bilateral B-lines
timeFrame: up to 12 months
Secondary outcomes:
measure: Accuracy of Paramedics' assessments of ultrasound for interpretation of lung sliding, pleural effusions, and pericardial effusions.
timeFrame: up to 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital-Saint Raphael Campus
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: David C Cone, MD
role: PRINCIPAL_INVESTIGATOR
References: