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

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05299229
• Other study ID #: 2000028142
• Status: Completed
• Start date: December 29, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Diagnostic Test:
• Echocardiogrpahy and non-invasive monitoring
Study participants will have echocardiography and non-invasive monitoring by chest/back sensors and a finger cuff.

Locations

Country	Name	City	State
United States	Yale University Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Primary	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	Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Primary	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	Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Primary	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	Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Primary	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	Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)
Primary	Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by transthoracic echocardiography	Systemic vascular resistance ranges 600-2000 dynes/sec*cm-5, higher values associated with more severe preeclampsia	Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)