Continuous Non-invasive Hemodynamic Monitoring in Early-onset Severe Preeclampsia: a Comparison of Echocardiography, Bioreactance, and Finger Cuff Measurements

Completed

• Conditions: Pre-Eclampsia
• Interventions: Diagnostic Test: Echocardiogrpahy and non-invasive monitoring

• Registration Number: NCT05299229
• Lead Sponsor: Yale University

Brief Summary

The purpose of this study is to compare the feasibility and accuracy of two methods of non-invasive hemodynamic assessments - bioreactance as assessed by non-invasive cardiac output monitoring (NICOM; Cheetah Medical) and pulse wave analysis as assessed by finger cuff arterial pressure (ClearSite, Edwards Life Sciences) - compared to hemodynamic assessments by intermittent echocardiography in early onset preeclampsia.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-12-29
• Study First Submitted: 2021-10-13
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• BP >160 or DBP >110
• gestational age between 20-34 weeks
• singleton pregnancy

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Exclusion Criteria

• prior diagnosis of chronic hypertension or hypertensive disorder of pregnancy
• multi-fetal pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart and vascular function	Echocardiogrpahy and non-invasive monitoring	All study participants will have echocardiography and non-invasive monitoring by chest/back sensors and a finger cuff to determine the best method of monitoring heart and vascular function in preeclampsia.

Primary Outcome Measures

Name	Time	Method
Change in cardiac output (L/min) as measured by NICOM (bioreactance) monitoring	Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)	Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia
Change in systemic vascular resistance (dynes/sec*cm-5) as measured by NICOM (bioreactance) monitoring	Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)	Systemic vascular resistance ranges 600-2000 dynes/sec\*cm-5, higher values associated with more severe preeclampsia
Change in Cardiac output (L/min) as measured by Clearsite (pulse wave analysis) monitoring	Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)	Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia
Change in Cardiac output (L/min) as measured by transthoracic echocardiography	Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)	Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia
Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by Clearsite (pulse wave analysis) monitoring	Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)	Systemic vascular resistance ranges 600-2000 dynes/sec\*cm-5, higher values associated with more severe preeclampsiaanalysis) monitoring
Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by transthoracic echocardiography	Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)	Systemic vascular resistance ranges 600-2000 dynes/sec\*cm-5, higher values associated with more severe preeclampsia

Trial Locations

Locations (1)

Yale University Hospital; 🇺🇸 New Haven, Connecticut, United States