- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mattias Günther, MD PhD
- Numéro de téléphone: 46812361000
- E-mail: mattias.gunther@ki.se
Lieux d'étude
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Stockholm County
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Stockholm, Stockholm County, Suède, 11883
- Recrutement
- Region Stockholm, all hospitals
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Contact:
- Mattias Günther, MD PhD
- Numéro de téléphone: 46812361000
- E-mail: mattias.gunther@ki.se
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Association between palpable pulses and systolic arterial blood pressure
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean arterial pressure associated with pulse palpability
Délai: During episodes of circulatory instability, up to 24 hours after inclusion
|
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
Délai: During episodes of circulatory instability, up to 24 hours after inclusion
|
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
|
|
Effect of vascular disease and vasoactive medication on pulse palpability
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-02475-01
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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