- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07609095
Peripheral pULSe Assessment and Arterial pRessure (PULSAR) (PULSAR)
Association Between Palpable Peripheral Pulses and Arterial Blood Pressure in Patients With Circulatory Shock: An International Prospective Multicenter Observational Cohort Study
This prospective multicenter observational study aims to investigate the relationship between palpable peripheral pulses and simultaneously measured arterial blood pressure in adult patients with circulatory shock or impending circulatory failure. Peripheral pulse palpation is routinely used in emergency medicine, trauma care, critical care, and cardiopulmonary resuscitation as a rapid clinical assessment of circulation. However, the association between palpable pulses and actual arterial blood pressure remains poorly validated.
Patients treated in emergency departments, intensive care units, operating rooms, and other acute care settings will undergo routine pulse palpation at predefined anatomical locations including carotid, femoral, and radial arteries. Simultaneously measured non-invasive and/or invasive arterial blood pressure values will be recorded from routine clinical monitoring systems. Additional clinical variables relevant to circulatory status will also be collected.
The study seeks to define blood pressure thresholds associated with pulse palpability and evaluate the agreement between invasive and non-invasive blood pressure measurements in patients with circulatory shock.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
The presence or absence of palpable peripheral pulses is widely used as a rapid bedside indicator of circulatory status during trauma care, emergency medicine, intensive care, and cardiopulmonary resuscitation. Advanced Trauma Life Support (ATLS) teaching traditionally assumes that palpable pulses at different anatomical sites correspond to specific systolic blood pressure thresholds. However, these assumptions are based on limited evidence from small observational studies.
This international multicenter prospective observational cohort study aims to investigate the relationship between palpable carotid, femoral, and radial pulses and simultaneously measured arterial blood pressure in adult patients with circulatory shock or impending circulatory failure.
Patients receiving routine hemodynamic monitoring with non-invasive blood pressure (NIBP) and/or invasive arterial blood pressure (IBP) monitoring will be included. Pulse palpation will be performed during routine clinical care without altering treatment or management.
The primary objective is to determine the association between pulse palpability and measured systolic blood pressure. Secondary objectives include identifying blood pressure thresholds associated with pulse palpability, evaluating agreement between invasive and non-invasive blood pressure measurements, and assessing whether patient factors such as vascular disease or vasoactive medication use influence pulse palpability.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Mattias Günther, MD PhD
- Numero di telefono: 46812361000
- Email: mattias.gunther@ki.se
Luoghi di studio
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Stockholm County
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Stockholm, Stockholm County, Svezia, 11883
- Reclutamento
- Region Stockholm, all hospitals
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Contatto:
- Mattias Günther, MD PhD
- Numero di telefono: 46812361000
- Email: mattias.gunther@ki.se
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Clinical signs of circulatory shock or impending circulatory failure
- Availability of non-invasive and/or invasive arterial blood pressure monitoring
- Pulse palpation possible without interfering with emergency care
Exclusion Criteria:
- Peripheral vascular conditions preventing reliable pulse palpation
- Major extremity amputation affecting assessment sites
- Clinical situations where study procedures interfere with life-saving treatment
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Patients With Circulatory Shock
Adult patients with clinical signs of circulatory shock or impending circulatory failure undergoing routine hemodynamic monitoring with non-invasive and/or invasive arterial blood pressure measurement during standard clinical care.
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Manual palpation of carotid, femoral, and radial pulses performed during routine clinical care in patients with circulatory instability.
Simultaneous arterial blood pressure measurements are recorded from standard monitoring systems.
No study-specific treatment or intervention is administered.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Association between palpable pulses and systolic arterial blood pressure
Lasso di tempo: During episodes of circulatory instability, up to 24 hours after inclusion
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Relationship between palpable carotid, femoral, and radial pulses and simultaneously measured systolic arterial blood pressure.
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During episodes of circulatory instability, up to 24 hours after inclusion
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mean arterial pressure associated with pulse palpability
Lasso di tempo: During episodes of circulatory instability, up to 24 hours after inclusion
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Relationship between pulse palpability and mean arterial pressure (MAP).
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During episodes of circulatory instability, up to 24 hours after inclusion
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Agreement between non-invasive and invasive blood pressure measurements
Lasso di tempo: During episodes of circulatory instability, up to 24 hours after inclusion
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Agreement between oscillometric non-invasive blood pressure and invasive arterial blood pressure measurements.
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During episodes of circulatory instability, up to 24 hours after inclusion
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Effect of vascular disease and vasoactive medication on pulse palpability
Lasso di tempo: During hospital admission, up to 30 days
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Influence of peripheral vascular disease, atherosclerosis, age, and vasoactive medications on pulse palpability.
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During hospital admission, up to 30 days
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Kim SH, Lilot M, Sidhu KS, Rinehart J, Yu Z, Canales C, Cannesson M. Accuracy and precision of continuous noninvasive arterial pressure monitoring compared with invasive arterial pressure: a systematic review and meta-analysis. Anesthesiology. 2014 May;120(5):1080-97. doi: 10.1097/ALN.0000000000000226.
- Gunther M, Dahlberg M, Rostami A, Azadali A, Arborelius UP, Linder F, Rostami E. Incidence, Demographics, and Outcomes of Penetrating Trauma in Sweden During the Past Decade. Front Neurol. 2021 Nov 15;12:730405. doi: 10.3389/fneur.2021.730405. eCollection 2021.
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-02475-01
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Shock
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Assistance Publique - Hôpitaux de ParisTraumabase Group; Capgemini Invent; Ecole polytechnique; EHESS (Ecole des hautes... e altri collaboratoriCompletatoFerite e lesioni | Shock emorragico | Shock traumaticoFrancia
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Haukeland University HospitalMinistry of Defence, NorwayCompletatoShock emorragico | Shock ipovolemicoNorvegia
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King's College Hospital NHS TrustUniversity Hospital BirminghamCompletatoShock emorragico traumaticoRegno Unito
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Arsenal Medical, Inc.ReclutamentoTrauma | Shock emorragico | Emorragia dissanguante | Shock; TraumaticoStati Uniti
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Assiut UniversitySconosciuto
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University of ManitobaCanadian Institutes of Health Research (CIHR); CancerCare ManitobaTerminatoShock settico | Shock vasodilatatorioCanada, Stati Uniti, Brasile, Grecia, India, Pakistan, Filippine
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Massachusetts General HospitalBeth Israel Deaconess Medical Center; Boston Medical Center; Tufts Medical Center; Lahey Clinic e altri collaboratoriReclutamento
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Jason SperryNational Heart, Lung, and Blood Institute (NHLBI)TerminatoShock emorragicoStati Uniti
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University of Texas Southwestern Medical CenterUniversity of Washington; Resuscitation Outcomes ConsortiumCompletato
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Artcline GmbHReclutamentoSepsi | Shock settico | Immunoparalisi nello Shock SetticoGermania
Prove cliniche su Peripheral Pulse Palpation
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ID3 MedicalAttivo, non reclutanteMalattia arteriosa perifericaBelgio, Francia
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Duke UniversityOdessey II SolutionsRitiratoSistemi di erogazione di ossigeno in quota
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Norwegian University of Science and TechnologyCompletatoStile di vita sedentarioNorvegia
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Encora, Inc.ReclutamentoMorbo di Parkinson | Tremore EssenzialeStati Uniti
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Norwegian University of Science and TechnologyTerminatoStile di vita sedentarioNorvegia
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Avantec VascularBright Research Partners; Yale Cardiovascular Research GroupReclutamentoMalattia arteriosa perifericaStati Uniti
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Nordic Institute for Studies of Innovation, Research...University of Agder; The Institute of Transport Economics, Norway; Fredrikstad... e altri collaboratoriReclutamentoInattività fisica | Alfabetizzazione sanitariaNorvegia
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Seers Technology Co., Ltd.CompletatoSaturazione di ossigenoCorea, Repubblica di
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Nuwellis, Inc.Completato
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Cardiovascular and Interventional Radiological...AbbottNon ancora reclutamentoIschemia minacciosa per gli arti cronici | Ischemia cronica minacciosa per gli arti