跳至主要内容
临床试验/NCT07522580
NCT07522580招募中不适用

Fluid-responsiveness Assessment Simplified by Electric Cardiometry in Children

University Hospital, Bordeaux4 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年7月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
42
试验地点
4
主要终点
Area under the ROC curve (AUROC, %) of ΔSV-ACICON to diagnose fluid responsiveness

研究概览

简要总结

In this study of diagnostic accuracy, the investigators aim to validate a faster, simpler, and noninvasive test of fluid-responsiveness in critically ill children. This test is based on an assessment of the hemodynamic effects of a standardized abdominal compression, using electrical cardiometry. This would help physicians to identify more easily which patient could benefit from a volume expansion, thus avoiding a potentially useless or even dangerous fluid expansion that could lead to fluid overload. To this end, the diagnostic accuracy of electrical cardiometry-based stroke volume (SV) variation induced by a standardized abdominal compression to predict fluid responsiveness (define as a 15% increase in echocardiographically measured SV after volume expansion) will be measured.

详细描述

Volume expansion is the cornerstone of acute circulatory failure treatment in children. However, inappropriate administration can lead to fluid overload, which is associated with poor outcome. Thus, the search for indicators to predict fluid responsiveness is a major issue in pediatric intensive care unit. In such an emergency context, this assessment must be as simple and fast as possible, and ideally non-invasive. In children, respiratory variability of peak aortic velocity is the most studied test and has an excellent diagnostic accuracy but is only validated in the absence of any spontaneous respiratory movement, a rare situation in practice. Recently, the abdominal compression maneuver has been investigated. This classical clinical maneuver induces a transient and reversible preload increase by increasing the venous return via the mobilization of the hepato-splanchnic venous reservoir. The echocardiographic evaluation of this maneuver can accurately predict fluid responsiveness. However, this echocardiographic assessment is a pitfall, as it is an operator-dependent, discontinuous and time-consuming examination. Therefore, electrical cardiometry could be interesting. This continuous and non-invasive cardiac output monitor could be an interesting alternative to evaluate the hemodynamic effects of the abdominal compression maneuver in order to predict fluid responsiveness.

Therefore, the investigators will evaluate the diagnostic accuracy of an abdominal compression maneuver for the diagnosis of fluid responsiveness in critically ill children, for whom the physician in charge prescribed a 10ml/kg volume expansion for circulatory failure. The index test will be the SV variation induced by an abdominal compression maneuver, with SV being measured with electrical cardiometry. Fluid responsiveness will be defined as a > 15% increase in echocardiographically-measured SV between baseline and within one hour after fluid expansion (gold standard test).

In this non-interventional, prospective, multi-center study of diagnostic accuracy, children requiring a 10ml/kg volume expansion will be included. After a prescription of 10 ml/kg volume expansion by the physician in charge, screening for inclusion and exclusion criteria will be performed by an investigator physician. If the patient is included, volume expansion will be delayed for a few minutes (<3 min) while an echocardiography and the index test are performed, but no supplemental blood test or invasive parameters will be collected. Another echocardiographic evaluation will be conducted within one hour after volume expansion, to assess response to fluid expansion (gold-standard test). Patients will be follow-up until PICU discharge (28 days maximum).

The index test is the ΔSV-ACICON: percentage of SV variation between baseline and during a standardized abdominal compression. Stroke volume will be assessed by electrical cardiometry, a noninvasive cardiac output monitoring.

The abdominal compression maneuver, a common clinical test in critically ill children, will be standardized as follow: a sphygmomanometer will be inflated with 80ml of air and will be applied to the center of the patient's abdomen. Then, the operator's hand will be placed on the sphygmomanometer (which is thus interposed between the patient's abdomen and the operator's hand) and a gentle manual anteroposterior compression will be performed, calibrated at 30 cmH2O according to the sphygmomanometer. Parameters of interest will be collected 30 seconds after the start of the compression.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Days 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age less than or equal to 8 years old
  • Hospitalization in a pediatric intensive care unit
  • Prescription by the attending physician of a fluid expansion of 10ml/kg
  • Use of a non-invasive cardiac output monitoring device (electrical cardiometry) as part of routine care

排除标准

  • Patient less than 37 weeks' corrected gestational age
  • Hemodynamic instability making the delay necessary for any test dangerous
  • Supine position contraindicated or deleterious
  • Impairment of echocardiographic acoustic window or restless patient making ultrasonography impossible
  • Opposition to participate expressed by the patient or by a parent or legal guardian
  • Intra-abdominal hypertension, painful abdominal palpation or abdominal surgery in the last 15 days

研究组 & 干预措施

Patient in paediatric intensive care unit

干预措施: validation a test of fluid-responsiveness in critically ill children (Diagnostic Test)

结局指标

主要结局

Area under the ROC curve (AUROC, %) of ΔSV-ACICON to diagnose fluid responsiveness

时间窗: between baseline and 1 hour

Description: The primary outcome measure of a diagnostic accuracy study is the discriminative ability of an index test (expressed as an area under the ROC curve) to diagnose a condition (defined by a positive gold-standard reference test). In this study: * The index test is ΔSV-ACICON = difference between stroke volume measured by electrical cardiometry (ml) during a calibrated abdominal compression (30mmHg for 30 seconds) and stroke volume measured by electrical cardiometry at baseline. * The condition is "fluid responsiveness" * The gold-standard reference test to diagnose fluid responsiveness is a stroke volume (SV) increase of at least 15% between baseline and after volume expansion: ΔSV-VE \> 15% = ((SV after volume expansion - SV at baseline) / SV at baseline) \> 15%. SV (ml) will be measured by transthoracic echocardiography as the product of left ventricular outflow tract surface (cm², from a parasternal long axis view) and left ventricular outflow tract velocity-time integral

次要结局

  • AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )(between baseline and 1 hour)
  • Diagnostic accuracy (AUROC, %) of all tests above to diagnose a significant increase (>15%) in mean arterial pressure after volume expansion(between baseline and 1 hour)
  • Subgroup analysis of the primary outcome: age, type of fluid expansion, ventilation status, circulatory physiology(between baseline and 1 hour)
  • Correlation between fluid responsiveness and the following.(At baseline; 1 hour ; Day 28.)
  • Correlation between fluid responsiveness and the following.(At baseline; After fluid expansion (see Primary Outcome Measure for Time Frame precise definition); Day 28.)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (4)

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