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

Hemodynamic Changes in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861132
• Other study ID #: NexValid13
• Status: Completed
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: June 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy singleton pregnancies at term scheduled for cesarean delivery

Exclusion Criteria:

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

• Reynaud phenomenon

Related Conditions & MeSH terms

• Hemodynamic Changes in Pregnancy

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Omenås IN, Tronstad C, Rosseland LA. Accuracy and trending abilities of finger plethysmographic blood pressure and cardiac output compared to invasive measurements during caesarean delivery in healthy women: an observational study. BMC Anesthesiol. 2020 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	Comparison of beat-to-beat data	15 minutes
Secondary	Cardiac output	Comparing beat-to-beat data of cardiac output	15 minutes