Validation of Nicom Device to Measure Stoke Volume Variation

Validation of NICOM for the Detection of Modification of Stroke Volume

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02485457

Acronym

NICOM-VAL

Enrollment

Registered

2015-06-30

Start date

2015-06-28

Completion date

2017-06-12

Last updated

2018-01-29

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

Conditions

Anesthesia

Brief summary

The purpose of this study is to evaluate the ability of NICOM (Noninvasive cardiac output monitor) to detect stroke volume variation induced by leg raising or fluid expansion during surgery

Interventions

PROCEDUREVolume loading

Volume loading with Ringer Lactate

DRUGRinger solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients undergoing general anesthesia with an expected duration exceeding two hours * gastrointestinal surgery, urological or gynecological surgery.

Exclusion criteria

* Difficulty of venous access. * Contraindication for the use of oesophageal Doppler * Contraindication for the use of Nicom * Contraindication for the use of bispectral index * Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame	Description
Stroke volume variation	6 hours	Stroke volumes measured by esophageal Doppler and by Nicom: at baseline, after leg passive rising, and after volume loading

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026