- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Mattias Günther, MD PhD
- Номер телефона: 46812361000
- Электронная почта: mattias.gunther@ki.se
Места учебы
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Stockholm County
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Stockholm, Stockholm County, Швеция, 11883
- Рекрутинг
- Region Stockholm, all hospitals
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Контакт:
- Mattias Günther, MD PhD
- Номер телефона: 46812361000
- Электронная почта: mattias.gunther@ki.se
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Association between palpable pulses and systolic arterial blood pressure
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean arterial pressure associated with pulse palpability
Временное ограничение: 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
Временное ограничение: 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
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Effect of vascular disease and vasoactive medication on pulse palpability
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026-02475-01
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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