Cardiac Flow Measurements in Pregnant Women by Non Invasive Techniques

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Cardiac Output
• Intervention / Treatment: Device: ICON measure; Device: USCOM; Device: trans thoracic echocardiography measure

Detailed Description

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.

The person performing the measurements will be an ultrasound laboratory technician trained in trans thoracic echocardiography according to Cardiology societies recommendations that consider that three months of full-time experience and 150 echocardiograms are required to be fully competent in echocardiography.

For measurements with USCOM and ICON, the technician will have an adequate training beforehand to formalize with the 2 devices and then perform the measurements during the dedicated consultations. The images for each measurement selected with each device will be stored on a USB key for USCOM and ICON and then transferred to KHEOPS by the research midwife respecting anonymization using the study number attributed for each patient. For the transthoracic ultrasound, the interest of the patient is paramount, these images will be transferred from the ultrasound machine to the secure server of the Universitary Hospital of Geneva (HUG) with the patient's identity and can be annexed to the integrated patient medical file so that these images can be used as a comparison in case of later consultation for cardiac symptoms. The images will be analyzed by the cardiologist investigator in the study who will have access to a secure database with patient identity and patient's study number so as to recover the cardiac images. He will calculate the cardiac output according to the following formula: the Cardiac output can be calculated after measuring the systolic ejection volume at the aortic annulus. At this level, the diameter of the annulus is measured during systole using two-dimensional ultrasound. Subsequently, the time-velocity integral of aortic ejection (VTIao) can be obtained using pulsed Doppler at the annulus. The systolic ejection volume is equal to the product of VTIao the diameter of the annulus squared multiplied by divided by 4 (VES = VTIao x ( D2/4) and the cardiac output will be equal to this value multiplied by the heart rate during measurement.

At the end of each examination, the laboratory technician will rate the objective values for each of the 2 devices: duration of the examination to obtain an interpretable measurement measured by a stopwatch that is started and then stopped when the measurement is performed in a satisfactory manner for the operator. Subjective values such as the feeling of comfort will be asked for each examination to the patient before moving on to the next examination according to a simple verbal scale : comfortable/ uncomfortable/ unbearable to be ticked on redcap. At the end of the consultation, the operator will assess the ease of measurement with the 3 devices using a simple verbal scale :easy/ moderately easy/ moderately difficult/ difficult to be ticked on redcap.

The measurement values for USCOM and ICON will be entered into redcap at the end of each consultation by the research midwife from the data on the USB ( Universal serial bus) stick transferred into KHEOPS software. The patient's medical data will be completed in redcap by the research midwife from the integrated patient record. The cardiac output measurement will be performed by the study cardiologist from the images transferred to the patient's integrated file (DPI) under the patient's identity and reopened thanks to the secure database associating the patient's identity and the unique study number accessible only to the investigators. The principal investigator and the statistician will interpret the anonymized raw data and will not be involved in the measurements. Due to the comparison of 3 devices easily recognizable by their shape, the study will be an open study. The stored images will be reviewed to ensure the quality of the Doppler spectrum for USCOM according to the Fremantle score and the measurement of cardiac output with transthoracic ultrasound at the level of the aortic valve. The Fremantle score is used to check the quality of the USCOM spectrum. The expected score for a good USCOM spectrum is 6. A score < 4 defines an insufficient spectrum quality. The echocardiography measurements will be used as a comparison as it is considered the gold standard for non-invasive cardiac output measurement.

The investigators need to include 100 patients by recruiting them in the first trimester of pregnancy and they will remain included until delivery. Some pregnancies may develop complications preventing from having the second measurement from 32 to 36 WA. The investigators need to obtain 100 measurements from 12 to 16 WA and 100 from 32 to 36 WA. The investigators will therefore have to re-include as many patients from 32 to 36 WA as those who gave birth before this 3rd trimester measurement. So this number of 100 patients can be more to obtain 100 measures at first trimester and 100 measures at third trimester. As investigators are comparing devices and the ease of use of these devices, without correlating the data to a clinical outcome, not having continuity between patients in the first and third trimester does not constitute a bias.

The duration of the project will be 18 months to obtain 100 measurements with the 3 devices from 12 to 16 WA and 100 measurements in the 3rd trimester of pregnancy.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bénédicte LE TINIER, MD; Phone Number: 0041795530127; Email: Benedictine.letinier@hcuge.ch
• Study Contact Backup: Name: Begona Marinez De Tejada, PD; Email: Begona.MartinezDeTejada@hcuge.ch

Study Locations

• Switzerland
  • Geneve, Switzerland, 1205
    • Recruiting
    • Hôpitaux universitaires de Genève
    • Contact: Bénédicte LE TINIER, MD; Phone Number: 0041795530127; Email: Benedictine.letinier@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: pregnant women; pregnant women with eligibility criteria with gestational age from 12 to 16+6/7 WA and then from 32 to 36+6/7 WA.

Device: ICON measure; 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.; Device: USCOM; Afterwards, measurements will be made with USCOM in left lateral position and 3 of the best spectra archived according to the Fremantle score.; Device: trans thoracic echocardiography measure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in cardiac output	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.	18 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systemic vascular resistance	To compare the systemic vascular resistance between USCOM and ICON.	18 month
patient satisfaction	measure with a verbal scale of 3 choices : comfortable, uncomfortable, insupportable for each measurement	18 month
user satisfaction	measure with a verbal scale of 4 choices: easy, moderately easy, moderately difficult, difficult for each measurement	18 month
examination time	Examination time in minutes for each measurement	18 month
stroke volume	To compare the stroke volume of USCOM and ICON to trans thoracic echocardiography between USCOM and ICON.	18 month

Collaborators and Investigators

• Sponsor: University of Geneva, Switzerland
• Investigators: Principal Investigator: Bénédicte LE TINIER, MD, Hôpitaux universitaires de Genève

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-D0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No