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NCT02485457 Clinical Trial

Validation of Nicom Device to Measure Stoke Volume Variation

Anesthesia Clinical Trial

— NICOM-VAL  

Official title:
Validation of NICOM for the Detection of Modification of Stroke Volume

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02485457
Other study ID # 2014/17
Secondary ID
Status Terminated
Phase N/A
First received June 26, 2015
Last updated January 26, 2018
Start date June 28, 2015
Est. completion date June 12, 2017

Study information
Verified date January 2018
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date June 12, 2017
Est. primary completion date June 12, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Volume loading
Volume loading with Ringer Lactate
Drug:
• Ringer solution

Locations
Country Name City State
France Hôpital Lariboisière Paris
France Marc Fischler Paris

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

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