NCT05299229 - Continuous Non-invasive Hemodynamic Monitoring in Early-onset Severe Preeclampsia: a Comparison of Echocardiography, Bioreactance, and Finger Cuff Measurements | Crick | Crick

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

N/ACompletedNCT05299229

Yale University12 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

12

Conditions

Interventions

Echocardiogrpahy and non-invasive monitoringDIAGNOSTIC_TEST

Study participants will have echocardiography and non-invasive monitoring by chest/back sensors and a finger cuff.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BP \>160 or DBP \>110 * gestational age between 20-34 weeks * singleton pregnancy Exclusion Criteria: * prior diagnosis of chronic hypertension or hypertensive disorder of pregnancy * multi-fetal pregnancy

Locations (1)

Yale University Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Change in cardiac output (L/min) as measured by NICOM (bioreactance) monitoring

Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia

Time frame: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)

Change in systemic vascular resistance (dynes/sec*cm-5) as measured by NICOM (bioreactance) monitoring

Systemic vascular resistance ranges 600-2000 dynes/sec\*cm-5, higher values associated with more severe preeclampsia

Time frame: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)

Change in Cardiac output (L/min) as measured by Clearsite (pulse wave analysis) monitoring

Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia

Time frame: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)

Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by Clearsite (pulse wave analysis) monitoring

Systemic vascular resistance ranges 600-2000 dynes/sec\*cm-5, higher values associated with more severe preeclampsiaanalysis) monitoring

Time frame: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)

Change in Cardiac output (L/min) as measured by transthoracic echocardiography

Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia

Time frame: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)

Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by transthoracic echocardiography

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.