- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03309852
Emergency Department Assessment of Right Ventricular Function and Size in the Post Cardiac Arrest Patient
Studieoversikt
Status
Detaljert beskrivelse
The use of point of care ultrasound (PoCUS) has grown rapidly. The incorporation of PoCUS in the assessment of patients in shock and to identify a reversible etiology to a patients cardiac arrest is widely practiced and endorsed by several organizations. While often overlooked, the right ventricle (RV) plays a critical role and often can provide clues to the etiology of a patient who is in shock. The right ventricle is very unique, as its anatomic structure, and function are markedly different then the left ventricle. What is often assessed is the size of the right ventricle. If dilated, which is defined as being >0.6 times that of the left ventricle, this could be indicative of elevated right sided pressures. In the right clinical context this may be caused by an acute pulmonary embolus. While this particular finding may raise clinical suspicion of acute right ventricular strain, point of care ultrasound cannot safely rule out acute pulmonary embolism. Several publications demonstrate the use of thrombolytics if a dilated RV is seen on PoCUS. This applies in patients with cardiac function who have not sustained a cardiac arrest. But in those patients who do sustain a cardiac arrest, these patients fall into a black hole of PoCUS findings related to the right ventricle. The international liaison committee on resuscitation has urged caution due to the unknown PoCUS findings during cardiac arrest. If one were to presume a dilated RV in a setting of a patient who sustained cardiac arrest was due to a pulmonary embolus, thrombolytics would be indicated. However, exposing the patient to thrombolytics, which in themselves carry a hemorrhage risk of 20%, is not a benign decision. Thus PoCUS findings as they pertain to the RV, in patient who sustain a cardiac arrest are unknown how they clinically correlate. Literature from critical care demonstrates that the right ventricle dilates, exhibits RV dysfunction, and carries a worse prognosis then that of the left ventricle. Recent animal data suggests that RV dilatation does occur in a porcine induced cardiac arrest model. To date, no human assessment of RV function and size in the immediate post-arrest state exists, and clearly a need to study this is evident.
objectives and hypothesis Objectives To assess the right ventricular function and size in patients who are immediately post-arrest patients.
Hypothesis Our hypothesis is that right ventricular dysfunction and dilatation is prevalent in the patients who are in cardiac arrest and in the post-cardiac arrest patient population, irrespective of they etiology of their cardiac arrest.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Tomislav Jelic, MD
- Telefonnummer: 2048990802
- E-post: tjelic@gmail.com
Studiesteder
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3A1R9
- Rekruttering
- Health Sciences Centre
-
Ta kontakt med:
- Tomislav Jelic, MD
- Telefonnummer: 2048990802
- E-post: tjelic@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Any post cardiac arrest patient who achieves return of spontaneous circulation that can have their RV assessed with point of care echo cardiography within 1 hour of ROSC.
Exclusion Criteria:
- Significant hemodynamic instability, pregnancy, incarcerated patients, age <18.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Right ventricular dysfunction
Tidsramme: 12 months
|
Assessment of RV dysfunction in post cardiac arrest patients.
|
12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Tomislav Jelic, MD, University of Manitoba, Health Sciences Centre
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B2017:104
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Hjertestans
-
University of AarhusFullførtHjertestans | Hypotermi | Post Cardiac Arrest SyndromeDanmark
-
Russian Federation of Anesthesiologists and ReanimatologistsRekrutteringPost Cardiac Arrest SyndromeDen russiske føderasjonen
-
University of AarhusUkjentHjertestans utenfor sykehus | Post Cardiac Arrest SyndromeDanmark
-
Impulse DynamicsRekrutteringEvaluer sikkerheten og brukbarheten til ODOCOR II Intra-cardiac LeadSpania, Tyskland, Italia
-
University Medical Center GroningenUkjentAkuttmedisinske tjenester | Hjertestans utenfor sykehus | Post Cardiac Arrest Syndrome
-
University of FlorenceSandro Gelsomino; Edvin Prifti; Francesco Cabrucci; Marco Bugetti; Orlando Parise og andre samarbeidspartnereRekrutteringKardiogent sjokk | Ekstrakorporeal membran oksygeneringskomplikasjon | Post-hjertekirurgi | Ekstrakorporal livsstøtte | Post Cardiac Arrest SyndromeItalia
-
Hasse Moller-SorensenFullførtSammenligning av CardioQ og Thermodilution Derived Cardiac Output-målingerDanmark
-
Christian HassagerFullførtSystemisk inflammatorisk responssyndrom | Hjertestans | Hjertestans utenfor sykehus | Nevrologisk skade | Hjertestans med vellykket gjenopplivning | Post Cardiac Arrest SyndromeDanmark
-
Mansoura UniversityFullført
-
Reham SameehAssiut UniversityUkjentCardiac Magnetic Resonance Imaging ved ikke-iskemisk kardiomyopati