- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Mattias Günther, MD PhD
- 전화번호: 46812361000
- 이메일: mattias.gunther@ki.se
연구 장소
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Stockholm County
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Stockholm, Stockholm County, 스웨덴, 11883
- 모병
- Region Stockholm, all hospitals
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연락하다:
- Mattias Günther, MD PhD
- 전화번호: 46812361000
- 이메일: mattias.gunther@ki.se
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Association between palpable pulses and systolic arterial blood pressure
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean arterial pressure associated with pulse palpability
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026-02475-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
충격에 대한 임상 시험
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Centre Hospitalier Universitaire Dijon모병Norepinephrine-retractory vasoplegic shock 환자프랑스
Peripheral Pulse Palpation에 대한 임상 시험
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Amplitude Vascular Systems, Inc.모병
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[Redacted]보류말초 동맥 질환 | 말초 동맥 폐색 질환 | 인주 | PAD - 말초 동맥 질환 | 만성 총 폐색 | 동맥 폐색
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AngioSafe, Inc.Veranex, Inc.완전한
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Nordic Institute for Studies of Innovation, Research...University of Agder; The Institute of Transport Economics, Norway; Fredrikstad municipality... 그리고 다른 협력자들모병
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ID3 Medical모병
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ID3 Medical모집하지 않고 적극적으로