Validation of Nicom Device to Measure Stoke Volume Variation

Not Applicable

Terminated

• Conditions: Anesthesia
• Interventions: Procedure: Volume loading; Drug: Ringer solution

• Registration Number: NCT02485457
• Lead Sponsor: Hopital Foch

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-26
• Study Start: 2015-06-28
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-06-30
• Primary Completion: 2017-06-12
• Study Completion: 2017-06-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-26
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High volume	Volume loading	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)
High volume	Ringer solution	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)
Low volume	Ringer solution	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)
Low volume	Volume loading	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)

Primary Outcome Measures

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

Trial Locations

Locations (2)

Hôpital Lariboisière; 🇫🇷 Paris, France

Marc Fischler; 🇫🇷 Paris, France