Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06510
- Yale New Haven Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Comparatore attivo: Usual care
Usual care as determined by treating team.
Ultrasound may still be part of the workup per the treating team's discretion.
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Sperimentale: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time to appropriate intervention
Lasso di tempo: Within 30 days of presentation
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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.
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Within 30 days of presentation
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Diagnostic accuracy
Lasso di tempo: Within 30 days of presentation
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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.
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Within 30 days of presentation
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Diagnostic certainty
Lasso di tempo: Within 2 days of presentation
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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.
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Within 2 days of presentation
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Time to disposition
Lasso di tempo: Within 2 days of presentation
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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.
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Within 2 days of presentation
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Total length of stay
Lasso di tempo: Within 30 days of presentation
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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.
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Within 30 days of presentation
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30-day in-hospital mortality
Lasso di tempo: Within 30 days of presentation
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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.
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Within 30 days of presentation
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Duration of POCUS
Lasso di tempo: Within 2 days of presentation
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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.
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Within 2 days of presentation
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Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Return visits with missed diagnosis
Lasso di tempo: Within 30 days of presentation
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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.
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Within 30 days of presentation
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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Christopher Moore, MD, Yale University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattia cardiovascolare
- Malattie vascolari
- Malattie del sistema nervoso
- Malattie delle vie respiratorie
- Disturbi respiratori
- Dolore
- Manifestazioni neurologiche
- Manifestazioni neurocomportamentali
- Attributi della malattia
- Segni e sintomi, respiratori
- Incoscienza
- Disturbi della coscienza
- Emergenze
- Dolore al petto
- Ipotensione
- Sincope
- Dispnea
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 1605017729
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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