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Clinical Trials/NCT01861132
NCT01861132
Completed
Not Applicable

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

Oslo University Hospital1 site in 1 country20 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemodynamic Changes in Pregnancy
Sponsor
Oslo University Hospital
Enrollment
20
Locations
1
Primary Endpoint
Systolic blood pressure
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
February 2014
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Leiv Arne Rosseland

Head for R&D department

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • Healthy singleton pregnancies at term scheduled for cesarean delivery

Exclusion Criteria

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

Outcomes

Primary Outcomes

Systolic blood pressure

Time Frame: 15 minutes

Comparison of beat-to-beat data

Secondary Outcomes

  • Cardiac output(15 minutes)

Study Sites (1)

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