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

Completed

• Conditions: Hemodynamic Changes in Pregnancy

• Registration Number: NCT01861132
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-23
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Healthy singleton pregnancies at term scheduled for cesarean delivery

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure	15 minutes	Comparison of beat-to-beat data

Secondary Outcome Measures

Name	Time	Method
Cardiac output	15 minutes	Comparing beat-to-beat data of cardiac output

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway