Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638649
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638649


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: David C Cone, MD Yale School of Medicine
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02638649    
Other Study ID Numbers: 1511016808
First Posted: December 23, 2015    Key Record Dates
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:
Layout table for MeSH terms
Pneumonia
Dyspnea
Pulmonary Edema
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Signs and Symptoms, Respiratory