Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath

NCT ID: NCT02638649

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-09-15

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.

Conditions

Pneumonia; Pulmonary Edema; Dyspnea

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Lung ultrasound

Intervention Type: PROCEDURE

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.

ultrasound

Intervention Type: DEVICE

Interventions

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.

Intervention Type: PROCEDURE

ultrasound

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David C Cone, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale-New Haven Hospital-Saint Raphael Campus

New Haven, Connecticut, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1511016808

Identifier Type: -

Identifier Source: org_study_id