Validation of a Non-invasive Hemodynamic Monitor (NexFin) in Pregnant Women

Validation of Non-invasive Monitoring of Blood Pressure and Cardiac Output in Healthy Pregnant Women During Cesarean Section

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01861132

Enrollment

Registered

2013-05-23

Start date

2013-05-31

Completion date

2014-02-28

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Changes in Pregnancy

Keywords

Pregnancy, cesarean delivery, blood pressure, cardiac output

Brief summary

Blood pressure and cardiac output can be measured invasively in pregnant women. Non-invasive monitoring devices are desirable, but until now, no equipment has proven validity. This study aims at validating the non-invasive monitoring device NexFin (second generation Finometer) in pregnant women.

Detailed description

Validation will be a direct beat-to-beat comparison of data from NexFin and the invasive measurements of blood pressure and calibrated cardiac output as an integrated part of LiDCO Plus. Both comparison of absolute values and the two different devices trending abilities will be analyzed.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Healthy singleton pregnancies at term scheduled for cesarean delivery

Exclusion criteria

* Twins, or multiple gestation, pre-eclampsia, gestational hypertension * Reynaud phenomenon

Design outcomes

Primary

Measure	Time frame	Description
Systolic blood pressure	15 minutes	Comparison of beat-to-beat data

Secondary

Measure	Time frame	Description
Cardiac output	15 minutes	Comparing beat-to-beat data of cardiac output

Countries

Norway

Outcome results