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Completed

NCT Number: NCT02638649

Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Hospital, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung ultrasound

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

Device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 23, 2015
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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