Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Dan Li, MD, PhD
- Telefonní číslo: +86-15623420855
- E-mail: lidanld@hust.edu.cn
Studijní záloha kontaktů
- Jméno: Yuan Yu, MD, PhD
- Telefonní číslo: +86-13971256590
- E-mail: yuyuanwhuh@hust.edu.cn
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
Inclusion Criteria:
- Age ≥18 years, admitted to the intensive care unit;
- Diagnosed with sepsis according to Sepsis-3 criteria: suspected or confirmed infection with an acute increase in SOFA score ≥2 points from baseline;
- Requiring hemodynamic monitoring for volume assessment and fluid resuscitation due to sepsis;
- Successfully inserted with central venous catheter and radial arterial catheter, meeting the technical requirements for PiCCO and APCO measurements;
- Informed consent signed by the patient or legal surrogate.
Exclusion Criteria:
- Severe arrhythmia (e.g., atrial fibrillation, ventricular tachycardia) precluding pulse contour analysis;
- Abnormal arterial access site (e.g., severe radial artery disease, arterial malformation) compromising the quality of invasive blood pressure measurement;
- Contraindications to ultrasound examination (e.g., severe thoracic deformity, massive pleural effusion, large intrathoracic space-occupying lesion) that prevents acquisition of clear ultrasound images;
- Contraindications for PiCCO monitoring (e.g., hemorrhagic disorders, aortic aneurysm, large-vessel vasculitis, pulmonary embolism, during extracorporeal circulation);
- Expected ICU stay ≤ 48 hours;
- Any other conditions judged unsuitable for enrollment by the investigator.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Agreement in fluid resuscitation decision-making between PiCCO and APCO
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage error of cardiac output (CO) between PiCCO and APCO
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Yuan Yu, MD, PhD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ICU2026016
- UHCT-IEC-SOP-016-03-01 (Jiný identifikátor: Medical Ethics Committee, Un)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
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