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

27 februari 2020 uppdaterad av: Yale University
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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

170

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Connecticut
      • New Haven, Connecticut, Förenta staterna, 06510
        • Yale New Haven Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Usual care
Usual care as determined by treating team. Ultrasound may still be part of the workup per the treating team's discretion.
Experimentell: Early POCUS
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to appropriate intervention
Tidsram: Within 30 days of presentation
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.
Within 30 days of presentation

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Diagnostic accuracy
Tidsram: Within 30 days of presentation
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.
Within 30 days of presentation
Diagnostic certainty
Tidsram: Within 2 days of presentation
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.
Within 2 days of presentation
Time to disposition
Tidsram: Within 2 days of presentation
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.
Within 2 days of presentation
Total length of stay
Tidsram: Within 30 days of presentation
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.
Within 30 days of presentation
30-day in-hospital mortality
Tidsram: Within 30 days of presentation
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.
Within 30 days of presentation
Duration of POCUS
Tidsram: Within 2 days of presentation
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.
Within 2 days of presentation

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Return visits with missed diagnosis
Tidsram: Within 30 days of presentation
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.
Within 30 days of presentation

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

  • Huvudutredare: Christopher Moore, MD, Yale University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2016

Primärt slutförande (Faktisk)

30 juni 2018

Avslutad studie (Faktisk)

30 juni 2018

Studieregistreringsdatum

Först inskickad

5 augusti 2016

Först inskickad som uppfyllde QC-kriterierna

5 augusti 2016

Första postat (Uppskatta)

10 augusti 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 februari 2020

Senast verifierad

1 februari 2020

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

IPD-planbeskrivning

No specific plans for now but would be open to sharing anonymized data.

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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