Validation of Nicom Device to Measure Stoke Volume Variation

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

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-28

Study Completion Date

2017-06-12

Brief Summary

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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

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Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Low volume

The protocol will follow the following steps :

* basal measurements (heart rate, arterial pressure, stroke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
* followed by passive leg rising and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
* second basal measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
* followed by low volume loading (250 ml of Ringer solution) and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)

Group Type EXPERIMENTAL

Volume loading

Intervention Type PROCEDURE

Volume loading with Ringer Lactate

Ringer solution

Intervention Type DRUG

High volume

The protocol will follow the following steps :

* basal measurements (heart rate, arterial pressure, stroke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
* followed by passive leg rising and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
* second basal measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
* followed by low volume loading (500 ml of Ringer solution) and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)

Group Type EXPERIMENTAL

Volume loading

Intervention Type PROCEDURE

Volume loading with Ringer Lactate

Ringer solution

Intervention Type DRUG

Interventions

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Volume loading

Volume loading with Ringer Lactate

Intervention Type PROCEDURE

Ringer solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No