- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mattias Günther, MD PhD
- Número de teléfono: 46812361000
- Correo electrónico: mattias.gunther@ki.se
Ubicaciones de estudio
-
-
Stockholm County
-
Stockholm, Stockholm County, Suecia, 11883
- Reclutamiento
- Region Stockholm, all hospitals
-
Contacto:
- Mattias Günther, MD PhD
- Número de teléfono: 46812361000
- Correo electrónico: mattias.gunther@ki.se
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Association between palpable pulses and systolic arterial blood pressure
Periodo de tiempo: During episodes of circulatory instability, up to 24 hours after inclusion
|
Relationship between palpable carotid, femoral, and radial pulses and simultaneously measured systolic arterial blood pressure.
|
During episodes of circulatory instability, up to 24 hours after inclusion
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean arterial pressure associated with pulse palpability
Periodo de tiempo: During episodes of circulatory instability, up to 24 hours after inclusion
|
Relationship between pulse palpability and mean arterial pressure (MAP).
|
During episodes of circulatory instability, up to 24 hours after inclusion
|
|
Agreement between non-invasive and invasive blood pressure measurements
Periodo de tiempo: During episodes of circulatory instability, up to 24 hours after inclusion
|
Agreement between oscillometric non-invasive blood pressure and invasive arterial blood pressure measurements.
|
During episodes of circulatory instability, up to 24 hours after inclusion
|
|
Effect of vascular disease and vasoactive medication on pulse palpability
Periodo de tiempo: During hospital admission, up to 30 days
|
Influence of peripheral vascular disease, atherosclerosis, age, and vasoactive medications on pulse palpability.
|
During hospital admission, up to 30 days
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-02475-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Choque
-
German Center for Neurodegenerative Diseases (DZNE)University Hospital, BonnDesconocidoCambios cognitivos y cerebrales a largo plazo en sobrevivientes de sepsis y sus predictores (BonSEP)Sepsis severa con shock séptico | Sepsis severa sin shock sépticoAlemania
-
Indonesia UniversityTerminadoImpacto del tratamiento con heparina no fraccionada en dosis bajas sobre la inflamación en la sepsisSepsis severa con shock séptico | Sepsis severa sin shock sépticoIndonesia
-
Hospital de Santa Cruz, PortugalReclutamientoShock cardiogénico | Shock Cardiogénico Post Infarto de Miocardio | Shock cardiogénico agudoPortugal
-
Artcline GmbHReclutamientoSepticemia | Shock séptico | Inmunoparálisis en Shock SépticoAlemania
-
University of ZurichTerminado
-
Laiba QamarReclutamientoShock séptico | Shock Séptico Refractario a LíquidosPakistán
-
University Medicine GreifswaldDesconocidoSepsis Shock sépticoAlemania
-
University Hospital, GrenobleTerminadoPaciente inmunocompetente en shock sépticoFrancia
-
Centre Hospitalier Universitaire DijonTerminadoPacientes con shock sépticoFrancia
-
National Hepatology & Tropical Medicine Research...DesconocidoResolución de Shock Séptico con TerlipresinaEgipto
Ensayos clínicos sobre Peripheral Pulse Palpation
-
First Affiliated Hospital Xi'an Jiaotong UniversityXijing Hospital; Children's Hospital of Fudan University; Shaanxi Provincial People... y otros colaboradoresDesconocidoParálisis cerebral | Lesión Cerebral CrónicaPorcelana
-
[Redacted]RetenidoEnfermedad arterial periférica | Enfermedad arterial periférica oclusiva | ALMOHADILLA | EAP - Enfermedad Arterial Periférica | Oclusiones Totales Crónicas | Oclusión de la arteria
-
ID3 MedicalActivo, no reclutandoEnfermedad arterial periféricaBélgica, Francia
-
Avantec VascularBright Research Partners; Yale Cardiovascular Research GroupReclutamientoEnfermedad arterial periféricaEstados Unidos
-
Marc Bosiers, MDTerminadoAneurisma de la aorta toracoabdominal, sin mención de rotura | Aneurisma aórtico abdominal, sin mención de rupturaAlemania
-
Charite University, Berlin, GermanyCompany HeVaTechTerminado
-
Edgard Costa de VilhenaAmparo Maternal Maternidade SocialTerminadoExceso de peso | El embarazo | Trastorno mentalBrasil
-
a2 Milk Company Ltd.Xinhua Hospital, Shanghai Jiao Tong University School of MedicineTerminadoInfección respiratoria | Enfermedad diarreicaPorcelana
-
B. Braun Medical Inc.TerminadoComplicaciones asociadas con el dispositivoEstados Unidos