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Clinical Trials/NCT02485457
NCT02485457
Terminated
N/A

Validation of NICOM for the Detection of Modification of Stroke Volume

Hopital Foch2 sites in 1 country2 target enrollmentJune 28, 2015

Overview

Phase
N/A
Intervention
Volume loading
Conditions
Anesthesia
Sponsor
Hopital Foch
Enrollment
2
Locations
2
Primary Endpoint
Stroke volume variation
Status
Terminated
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 28, 2015
End Date
June 12, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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)

Intervention: Volume loading

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)

Intervention: Ringer solution

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)

Intervention: Volume loading

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)

Intervention: Ringer solution

Outcomes

Primary Outcomes

Stroke volume variation

Time Frame: 6 hours

Stroke volumes measured by esophageal Doppler and by Nicom: at baseline, after leg passive rising, and after volume loading

Study Sites (2)

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