Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath

• ClinicalTrials.gov Identifier: NCT02638649
• Recruitment Status: Completed
• First Posted: December 23, 2015
• Last Update Posted: March 23, 2020
• Sponsor: Yale University
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment
Pneumonia; Pulmonary Edema; Dyspnea	Procedure: Lung ultrasound; Device: ultrasound

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

• Study Type: Observational
• Actual Enrollment: 69 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
• Study Start Date: September 2016
• Actual Primary Completion Date: September 15, 2018
• Actual Study Completion Date: September 15, 2018

Groups and Cohorts

Group/Cohort

Intervention/treatment

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.

Procedure: Lung ultrasound; 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.; Device: ultrasound

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Accuracy of Paramedics' assessments of ultrasound for interpretation of lung sliding, pleural effusions, and pericardial effusions. [ Time Frame: up to 12 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with dyspnea

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

Contacts and Locations

Locations

United States, Connecticut

Yale-New Haven Hospital-Saint Raphael Campus

New Haven, Connecticut, United States, 06517

Yale New Haven Hospital

New Haven, Connecticut, United States, 06519-1362

Sponsors and Collaborators

Yale University

Investigators

• Principal Investigator: David C Cone, MD; Yale School of Medicine

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02638649
• Other Study ID Numbers: 1511016808
• First Posted: December 23, 2015
• Last Update Posted: March 23, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Yale University:

lung ultrasound

Additional relevant MeSH terms:

Pneumonia; Dyspnea; Pulmonary Edema; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Respiration Disorders; Signs and Symptoms, Respiratory