Comparison of Manual PAOP and Automatic PAOP (Smart Wedge)

Официальное название

Comparison of Pulmonary Artery Occlusion Pressure (PAOP) Measurements Performed by an Expert Versus Those Obtained Using the SmartWedge Algorithm in Patients Undergoing Pulmonary Artery Catheterization (Swan-Ganz IQ™).

Обзор

The pulmonary artery catheter (Swan-Ganz) is a standard tool in intensive care for measuring and monitoring the pulmonary artery occlusion pressure (PAOP). The Swan-Ganz IQ™ model also allows automatic measurement to reduce the risk of error (Smart Wedge). However, the concordance between this automatic method and the manual method remains poorly studied in real clinical conditions and may vary depending on certain clinical situations. This study therefore aims to compare the PAOP automatically measured (Smart Wedge) with the manual PAOP measurement at bedside based on data collected in clinical practice.

Подробное описание

The pulmonary artery catheter (or Swan-Ganz catheter) is a standard tool for measuring and monitoring PAOP in intensive care. It measures PAOP manually, which is considered the gold standard method. The Swan-Ganz IQ™ model also offers automatic measurement of PAOP during inflation of the balloon in the pulmonary artery (Smart Wedge). The ability to automatically measure PAOP would decrease the risk of error. However, the concordance between manual PAOP (reference method) and automatic PAOP (Smart Wedge) remains poorly evaluated by independent data in real clinical conditions. Furthermore, this agreement may vary depending on the clinical situation. In this context, this study aims to compare the manual PAOP measurement and the automatic PAOP measurement (Smart Wedge) based on data collected in the clinical setting.

Вмешательства

• Диагностический тест Swan-Ganz IQ™, Smart Wedge
  Swan-Ganz IQ™ is a device that provides continuous measurement of cardiac index by analyzing the right ventricular pressure wave. The "Smart Wedge" module provides an automated estimate of PAPO as well as a signal quality indicator ("wedge index"), designed to assess the reliability of the measurement and alert the operator in the event of an unusable signal. This algorithm underwent regulatory validation based on retrospective data compared to an expert interpretation of selected tracings, lead

Первичные конечные точки

• Assess the agreement between PAOP values measured by the "Smart Wedge" algorithm and PAOP values analyzed by an expert in patients in shock who are being monitored via a pulmonary artery catheter (Swan Ganz IQ) [Срок оценки: 1 day]

Вторичные конечные точки (3)

• Identify situations where there is a risk of discrepancy in the "Smart Wedge" value [Срок оценки: 1 day]
• Assess the variability between PAOP values measured by the Smart Wedge algorithm and those measured by an expert. [Срок оценки: 1 day]
• Assess the agreement between the PAPO value provided by the "Smart Wedge" algorithm and the PAPO value used in clinical practice, and compare it to the agreement observed between the algorithm and the expert interpretation performed retrospectively. [Срок оценки: 1 day]

Критерии участия

Критерии включения

• Age ≥18 years;
• Admission to an intensive care unit;
• Presence of a Swan-Ganz IQ™ pulmonary artery catheter placed as part of patient care;
• Measurement of pulmonary artery occlusion pressure (PAOP) performed by the attending clinician as part of patient care.

Критерии исключения

• Pregnancy;
• Court-ordered protective measures.
• Refusal to participate by the patient's family members or the patient themselves.
• Cardiac output measurements by thermodilution or by continuous cardiac output analysis that cannot be interpreted.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07703592 · SMART-PAPO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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