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Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department

Primary Purpose

Chest Pain, Dyspnea, Syncope

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point-of-care ultrasound
Usual care
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chest Pain focused on measuring Ultrasonography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chief complaint of chest pain, dyspnea (either sudden onset or increased severity of chronic dyspnea), syncope, or hypotension (systolic blood pressure <100 or shock index [heart rate divided by systolic blood pressure] >1)

Exclusion Criteria:

  • <18 years old
  • Prisoner or ward of the state
  • Trauma
  • High acuity requiring treatment in resuscitation room
  • Obvious cause of symptoms (e.g. acute GI bleed causing hypotension)
  • Any form of "do not resuscitate" (DNR) order
  • Roomed in hall of emergency department (location not amenable to ultrasound protocol)

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

Early POCUS

Arm Description

Usual care as determined by treating team. Ultrasound may still be part of the workup per the treating team's discretion.

Point-of-care ultrasound protocol will involve cardiac views (for pericardial effusion, left ventricular function, left and right ventricular equality, aortic root dilation, and inferior vena cava status), lung views (for pneumothorax, signs of alveolar interstitial syndrome), abdominal views for free fluid, and a view of the abdominal aorta for aneurysm.

Outcomes

Primary Outcome Measures

Time to appropriate intervention
Based on final diagnosis as determined by final review of the patient's overall visit in the medical record, it will be determined what the appropriate intervention(s) that the patient should have received. Subsequently, the amount of time that elapsed (minutes) between time the patient was roomed in the emergency department (ED) and time to when they received the intervention will be collected. All these time points are readily available in the electronic medical record in the patient care timeline. This outcome will help determine whether early POCUS affects how quickly patients receive appropriate intervention.

Secondary Outcome Measures

Diagnostic accuracy
The treating team in the ED will be asked for their diagnostic impression of the patient's chief complaint at several points during the patient's time in the ED. These points will be (1) after the primary provider's initial assessment, (2) at time of disposition, and (3) if they are in the early POCUS group, after the POCUS findings are relayed to them. They will select their single most likely diagnosis each time, which will be compared against a final diagnosis as determined by final review of the patient's overall visit in the medical record (as this study's gold standard for diagnosis). This outcome will examine how often (percentage-wise) the treating team's diagnosis matches the final diagnosis as well as if early POCUS has any impact on helping physicians reach the correct diagnosis.
Diagnostic certainty
Similar to the outcome of diagnostic accuracy, the treating team in the ED will concomitantly be asked how certain they feel about their diagnosis on a five-point scale. The presence of any changes in certainty (i.e. proportion of patients for whom certainty changed) as well as how much change (e.g. increased certainty by 2 points) will be assessed. This outcome will determine if early POCUS affects physicians' certainty of diagnosis.
Time to disposition
This will be measured as amount of time (in minutes) that elapse between the time patient is roomed in the ED to time the treating team determines patient disposition. These timestamps are available in the medical record under the patient care timeline. This outcome will examine if early POCUS affects the time it takes for the treatment team to achieve a disposition plan for the patient.
Total length of stay
This will be measured as time (in days) between the patient's date of presentation and date of discharge. This outcome will examine if early POCUS affects the amount of time that patients stay in the hospital.
30-day in-hospital mortality
Patients will be followed in their medical record for up to 30 days after their initial presentation to assess for in-hospital mortality rate. This outcome will examine if early POCUS leads to any significant difference in patient mortality rate compared to usual care.
Duration of POCUS
For the early POCUS group, this will be measured as the amount of time (in minutes) between the time the ultrasound is started and the time the last image is captured. All images/video clips acquired by the ultrasound machine have a timestamp. A blank image will be captured at the start of the exam for the initial timestamp. This outcome will examine how time-consuming our POCUS exam is and provides a sense of how disruptive the introduction of POCUS might be if it were implemented routinely.

Full Information

First Posted
August 5, 2016
Last Updated
February 27, 2020
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02861508
Brief Title
Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department
Official Title
Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the proposed research is to examine whether incorporating point-of-care ultrasound (POCUS) early in diagnostic work-up of cardiopulmonary complaints will affect diagnosis, time to condition-specific intervention, and ultimately patient outcomes compared to usual care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Dyspnea, Syncope, Hypotension
Keywords
Ultrasonography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care as determined by treating team. Ultrasound may still be part of the workup per the treating team's discretion.
Arm Title
Early POCUS
Arm Type
Experimental
Arm Description
Point-of-care ultrasound protocol will involve cardiac views (for pericardial effusion, left ventricular function, left and right ventricular equality, aortic root dilation, and inferior vena cava status), lung views (for pneumothorax, signs of alveolar interstitial syndrome), abdominal views for free fluid, and a view of the abdominal aorta for aneurysm.
Intervention Type
Other
Intervention Name(s)
Point-of-care ultrasound
Intervention Type
Other
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
Time to appropriate intervention
Description
Based on final diagnosis as determined by final review of the patient's overall visit in the medical record, it will be determined what the appropriate intervention(s) that the patient should have received. Subsequently, the amount of time that elapsed (minutes) between time the patient was roomed in the emergency department (ED) and time to when they received the intervention will be collected. All these time points are readily available in the electronic medical record in the patient care timeline. This outcome will help determine whether early POCUS affects how quickly patients receive appropriate intervention.
Time Frame
Within 30 days of presentation
Secondary Outcome Measure Information:
Title
Diagnostic accuracy
Description
The treating team in the ED will be asked for their diagnostic impression of the patient's chief complaint at several points during the patient's time in the ED. These points will be (1) after the primary provider's initial assessment, (2) at time of disposition, and (3) if they are in the early POCUS group, after the POCUS findings are relayed to them. They will select their single most likely diagnosis each time, which will be compared against a final diagnosis as determined by final review of the patient's overall visit in the medical record (as this study's gold standard for diagnosis). This outcome will examine how often (percentage-wise) the treating team's diagnosis matches the final diagnosis as well as if early POCUS has any impact on helping physicians reach the correct diagnosis.
Time Frame
Within 30 days of presentation
Title
Diagnostic certainty
Description
Similar to the outcome of diagnostic accuracy, the treating team in the ED will concomitantly be asked how certain they feel about their diagnosis on a five-point scale. The presence of any changes in certainty (i.e. proportion of patients for whom certainty changed) as well as how much change (e.g. increased certainty by 2 points) will be assessed. This outcome will determine if early POCUS affects physicians' certainty of diagnosis.
Time Frame
Within 2 days of presentation
Title
Time to disposition
Description
This will be measured as amount of time (in minutes) that elapse between the time patient is roomed in the ED to time the treating team determines patient disposition. These timestamps are available in the medical record under the patient care timeline. This outcome will examine if early POCUS affects the time it takes for the treatment team to achieve a disposition plan for the patient.
Time Frame
Within 2 days of presentation
Title
Total length of stay
Description
This will be measured as time (in days) between the patient's date of presentation and date of discharge. This outcome will examine if early POCUS affects the amount of time that patients stay in the hospital.
Time Frame
Within 30 days of presentation
Title
30-day in-hospital mortality
Description
Patients will be followed in their medical record for up to 30 days after their initial presentation to assess for in-hospital mortality rate. This outcome will examine if early POCUS leads to any significant difference in patient mortality rate compared to usual care.
Time Frame
Within 30 days of presentation
Title
Duration of POCUS
Description
For the early POCUS group, this will be measured as the amount of time (in minutes) between the time the ultrasound is started and the time the last image is captured. All images/video clips acquired by the ultrasound machine have a timestamp. A blank image will be captured at the start of the exam for the initial timestamp. This outcome will examine how time-consuming our POCUS exam is and provides a sense of how disruptive the introduction of POCUS might be if it were implemented routinely.
Time Frame
Within 2 days of presentation
Other Pre-specified Outcome Measures:
Title
Return visits with missed diagnosis
Description
The patient's medical record will be followed for 30 days after initial presentation for the presence of any repeat visits with the healthcare system for a similar chief complaint. If so, that repeat visit will be reviewed for the presence of a different diagnosis than that established at the original visit, which would suggest that the correct diagnosis had been missed at that time. It will then be determined what the percentage of patients is with such visits out of all patients in the study. This outcome will examine if POCUS helps with picking up diagnoses that might be missed otherwise.
Time Frame
Within 30 days of presentation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chief complaint of chest pain, dyspnea (either sudden onset or increased severity of chronic dyspnea), syncope, or hypotension (systolic blood pressure <100 or shock index [heart rate divided by systolic blood pressure] >1) Exclusion Criteria: <18 years old Prisoner or ward of the state Trauma High acuity requiring treatment in resuscitation room Obvious cause of symptoms (e.g. acute GI bleed causing hypotension) Any form of "do not resuscitate" (DNR) order Roomed in hall of emergency department (location not amenable to ultrasound protocol)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Moore, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No specific plans for now but would be open to sharing anonymized data.

Learn more about this trial

Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department

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