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

NCT ID: NCT01861132

Last Updated: 2021-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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Hemodynamic Changes in Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy pregnant women

Healthy pregnant women for C-section under spinal anesthesia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Healthy singleton pregnancies at term scheduled for cesarean delivery

Exclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Leiv Arne Rosseland

Head for R&D department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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Omenas 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 Jun 27;20(1):157. doi: 10.1186/s12871-020-01078-8.

Reference Type RESULT
PMID: 32593297 (View on PubMed)

Other Identifiers

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NexValid13

Identifier Type: -

Identifier Source: org_study_id

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