跳至主要内容
临床试验/NCT06114147
NCT06114147招募中不适用

Cardiac Flow Measurements in Pregnant Women by Non Invasive Techniques: Comparison Between USCOM, ICON and Trans Thoracic Echography

University of Geneva, Switzerland2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
2
主要终点
difference in cardiac output

研究概览

简要总结

the goal of this clinical trial is to compare the measurement of cardiac output, systolic ejection volume and vascular filling in pregnant women with the new non-invasive measurement techniques of the Index of contractility monitor (ICON) and the Ultra Sonic Cardiac Output Monitor (USCOM) in pregnant women compared to trans-thoracic ultrasound as the gold standard of non-invasive techniques The Secondary objective is to evaluate patient comfort between the 3 techniques, examination time and examiner satisfaction.

The main question it aim to answer is the absence or a low difference in cardiac output measurement ( less than 30 %) between the non invasive measurement methods ( USCOM/ICON) and the trans thoracic cardiac echography in pregnant women in the first and third trimester.

详细描述

It is a Prospective cross sectional study

The study design does not allow for randomisation or double-blinding.

Patients will be enrolled in the first trimester of pregnancy and offered the study at the 10 gestational week (GW) consultation. After signing and giving informed consent, the research nurse or midwife will schedule the specific consultation from between 12 to and 16+6 Weeks of Amenorrhea (WA) (cardiac output rise from 5 weeks of gestation to 16 weeks of gestation and then stay at the same level) and in the 3rd trimester from between 32 to and 36+6 WA. Patients will therefore be included from the beginning of their pregnancy until their delivery, i.e. approximately 7 months All pregnant patients will each have a measurement in left lateral decubitus by the 3 devices from 12 to 16+6 WA and another set of measurement between 32 and 36+6 WA.

During the specific consultations organized (eg on Tuesday mornings), a designed medical professional will carry out measurement with the 3 different devices in a room accordingly with an examination table allowing the left lateral decubitus. At each consultation parameters such as weight, height of the patient, cardiac frequency, blood pressure will be recorded.

Each consultation is expected to last 30 minutes: The ICON will be placed at the beginning of the consultation and the measurements will be taken at the same time as the trans thoracic ultrasound in the left lateral decubitus position. The trans thoracic echography would be carried out with cardiac classic sections to ensure the structural cardiac and valvular normality and then sections repeated 3 times over 10 minutes will be carried out to calculate the cardiac output. Afterwards, measurements will be made with USCOM in left lateral position and 3 of the best spectra archived according to the Fremantle score.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Any pregnant person over 16 years old followed at the prenatal consultation of the maternity ward of the Geneva University Hospitals.

排除标准

  • Drug or alcohol abuse,
  • Miscarriage or intra uterine demise before the first exam.
  • Inability to follow the procedures of the investigation, e.g. due to psychological disorders, dementia, etc. of the subject,
  • Inability to give an informed consent.
  • preexisting or congenital cardiopathy
  • Structural abnormalities of hearth or valves diagnosed in the first Trans Thoracic Echocardiography screening

结局指标

主要结局

difference in cardiac output

时间窗: 18 month

Absence/low difference in cardiac output measurement (less than 30% difference) between the new non-invasive measurement methods (USCOM, ICON) and the trans thoracic echocardiography in pregnant women in the first and third trimester of pregnancy compared to the reference method which is trans thoracic echocardiography.

次要结局

  • user satisfaction(18 month)
  • examination time(18 month)
  • systemic vascular resistance(18 month)
  • stroke volume(18 month)
  • patient satisfaction(18 month)

研究者

发起方
University of Geneva, Switzerland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bénédicte LE TINIER

doctor in medecine,assistant to the head of department in charge of the antenatal consultation unit, principal investigator

University of Geneva, Switzerland

研究点 (2)

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