Evaluating the Use of Prehospital Lung Ultrasound in EMS: A Multicenter Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey
About this trial
The goal of this prospective nonrandomized study is to determine if prehospital lung ultrasound findings result in a change in patient management. This study will look at how lung ultrasound exam improves diagnosis of respiratory distress in patients being treated by Emergency Medical Services, such as patients with heart failure. Additional questions include:
* How well can paramedics obtain and interpret ultrasound images? * How does ultrasound use change treatment received by patients? * How does ultrasound use impact patient outcomes? Participants will receive a lung ultrasound exam, but otherwise receive standard evaluation and care. Patients who receive ultrasound will be compared to those who did not receive ultrasound for logistical reasons and patients from before the use of ultrasound. Ultrasound will not be withheld from any patient for the purposes of the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient treated by Emergency Medical Services
Complaint of dyspnea
Oxygen saturation <94% on room air
Abnormal lung sounds
Disqualifiers
Pediatric patients (<18)
Traumatic etiology
Cardiac arrest at any point prehospitally
No ultrasound-trained paramedic involved in patient's care
Trial design
Design model
Parallel
Treatments tested in this trial
Pulmonary ultrasound
Diagnostic testUltrasound of up to six lung zones (1, 2, and 4) will be obtained. Paramedics will assess for the presence of B lines.
Treatment groups
1,000 Participants
are divided into 3 treatment groupsGroup A: Patients who receive ultrasoundActive comparator 1 intervention
Group B: Patients before ultrasound implementationNo intervention 0 interventions
Group C: Patients who do not receive ultrasoundNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Frequency with which prehospital lung ultrasound findings result in a change in patient management by EMS
Frequency of management changes will be compared from before prehospital ultrasound was used to after prehospital ultrasound has been implemented.
Time frame
From time of patient encounter to patient handoff at the hospital. (anticipated average of one hour)Secondary outcomes
1
Survival to discharge
Time frame
At time of hospital discharge (anticipated average one week)2
Percent of prehospital diagnoses agreeing with hospital diagnosis
Diagnostic accuracy
Time frame
At time of hospital discharge (anticipated average of one week)3
Whether or not patient is intubated by EMS or during hospital admission, recorded as yes or no
Time frame
EMS patient encounter to hospital discharge (anticipated average one week)4
Days on ventilator or non-invasive ventilation
Time frame
Hospital arrival to hospital discharge (anticipated average one week)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rutgers, The State University of New Jersey
Lead sponsor
Christiana Care Health Services
Collaborator
Cooper University Health Care
Collaborator
Hackensack Meridian Health
Collaborator
Source ClinicalTrials.gov
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