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Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care

2026년 11월 3일 업데이트: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Accuracy and Decision-Making Value of Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring for Hemodynamic Management in Critically Ill Patients Compared With PiCCO

This is a single-center prospective clinical study in the intensive care unit (ICU). Thirty adult patients with sepsis requiring hemodynamic monitoring and fluid resuscitation will be enrolled. All participants will undergo two hemodynamic monitoring modalities simultaneously: pulse indicator continuous cardiac output (PiCCO) (reference standard) and arterial pulse contour cardiac output (APCO, ultrasound-calibrated pulse-contour cardiac output). The study aims to evaluate the consistency of clinical decision-making for fluid resuscitation guided by APCO compared with PiCCO, and to verify the accuracy of cardiac output (CO) measured by APCO. No investigational drugs will be administered. A standardized fluid challenge will be performed based on clinical indications. Hemodynamic parameters, laboratory results, and adverse events will be collected throughout the ICU stay.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

Accurate hemodynamic assessment and fluid management are critical for septic patients in ICU. PiCCO using transpulmonary thermodilution is widely regarded as reference standard for cardiac output measurement, but it has limitations including high cost and potential catheter-related complications. APCO combines transthoracic echocardiography calibration with radial-artery pulse contour analysis, which may provide continuous cardiac output monitoring with lower complication risks.

In this prospective self-controlled study, 30 eligible adult sepsis patients fulfilling Sepsis-3 criteria will be recruited at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Each subject will undergo concurrent PiCCO and APCO measurements. Study visits include baseline screening (V1), dynamic monitoring when fluid infusion indication appears (V2), post-resuscitation assessment (V3), and follow-up until PiCCO catheter removal (V4). 500-mL crystalloid fluid challenge over 15 minutes will be conducted for patients with positive fluid responsiveness assessed by passive leg-raising test. Cardiac output (CO), stroke volume index (SVI) and other hemodynamic variables will be recorded synchronously after each fluid challenge. The primary endpoint is consistency of fluid-resuscitation clinical decisions between APCO and PiCCO, assessed by overall agreement rate and Kappa statistics. Secondary endpoints include bias, percentage error, Bland-Altman limits of agreement and correlation of CO values between two techniques. Safety outcomes include incidence of adverse events and device-related complications. Statistical analyses will be performed using SPSS and R software.

연구 유형

관찰

등록 (추정된)

30

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Adult critically ill patients with sepsis admitted to the intensive care unit, who require hemodynamic monitoring with PiCCO and APCO for fluid resuscitation and volume assessment.

설명

Inclusion Criteria:

  1. Age ≥18 years, admitted to the intensive care unit;
  2. Diagnosed with sepsis according to Sepsis-3 criteria: suspected or confirmed infection with an acute increase in SOFA score ≥2 points from baseline;
  3. Requiring hemodynamic monitoring for volume assessment and fluid resuscitation due to sepsis;
  4. Successfully inserted with central venous catheter and radial arterial catheter, meeting the technical requirements for PiCCO and APCO measurements;
  5. Informed consent signed by the patient or legal surrogate.

Exclusion Criteria:

  1. Severe arrhythmia (e.g., atrial fibrillation, ventricular tachycardia) precluding pulse contour analysis;
  2. Abnormal arterial access site (e.g., severe radial artery disease, arterial malformation) compromising the quality of invasive blood pressure measurement;
  3. Contraindications to ultrasound examination (e.g., severe thoracic deformity, massive pleural effusion, large intrathoracic space-occupying lesion) that prevents acquisition of clear ultrasound images;
  4. Contraindications for PiCCO monitoring (e.g., hemorrhagic disorders, aortic aneurysm, large-vessel vasculitis, pulmonary embolism, during extracorporeal circulation);
  5. Expected ICU stay ≤ 48 hours;
  6. Any other conditions judged unsuitable for enrollment by the investigator.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Agreement in fluid resuscitation decision-making between PiCCO and APCO
기간: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.

This outcome assesses the overall agreement rate and Kappa value for consistency of clinical fluid resuscitation decision-making guided by PiCCO and APCO measurements.
Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage error of cardiac output (CO) between PiCCO and APCO
기간: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.

This outcome assesses the percentage error of paired cardiac output measurements obtained by PiCCO transpulmonary thermodilution and APCO monitoring.
Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
Consistency of cardiac output trend changes after hemodynamic intervention
기간: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.

This outcome assesses the consistency of cardiac output trend changes detected by PiCCO transpulmonary thermodilution and APCO monitoring after hemodynamic intervention.
Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
Agreement of cardiac output evaluated by Bland-Altman analysis
기간: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.

Bland-Altman analysis is used to evaluate the agreement of cardiac output measured by PiCCO and APCO.
Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
Pearson correlation of CO between PiCCO and APCO
기간: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.

This outcome assesses the Pearson correlation coefficient of paired cardiac output measurements obtained by PiCCO transpulmonary thermodilution and APCO monitoring.
Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

수사관

  • 수석 연구원: Yuan Yu, MD, PhD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 1일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2026년 10월 13일

QC 기준을 충족하는 최초 제출

2026년 11월 3일

처음 게시됨 (실제)

2026년 11월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ICU2026016
  • UHCT-IEC-SOP-016-03-01 (기타 식별자: Medical Ethics Committee, Un)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared publicly due to patient privacy protection and local institutional data regulations. De-identified aggregate study results may be available upon reasonable request to the principal investigator.

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. .

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