Validation of Nicom Device to Measure Stoke Volume Variation (NICOM-VAL)

Hopital Foch

Status: Terminated

Conditions: Anesthesia

Treatments: Drug: Ringer solution; Procedure: Volume loading

Study type: Interventional

Funder types: Other

Identifiers

NCT02485457

2014/17

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Low volume

Experimental group

Description:

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)

Treatment:

Drug: Ringer solution

Procedure: Volume loading

High volume

Experimental group

Description:

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)

Treatment:

Drug: Ringer solution

Procedure: Volume loading