NCT02485457

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

June 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2017

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

June 26, 2015

Last Update Submit

January 26, 2018

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Stroke volume variation

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

    6 hours

Study Arms (2)

Low volume

EXPERIMENTAL

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)

Procedure: Volume loadingDrug: Ringer solution

High volume

EXPERIMENTAL

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)

Procedure: Volume loadingDrug: Ringer solution

Interventions

Volume loadingPROCEDURE

Volume loading with Ringer Lactate

High volumeLow volume
Ringer solutionDRUG
High volumeLow volume

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Lariboisière

Paris, 75010, France

Location

Marc Fischler

Paris, 75015, France

Location

MeSH Terms

Interventions

Ringer's Solution

Intervention Hierarchy (Ancestors)

Isotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2015

First Posted

June 30, 2015

Study Start

June 28, 2015

Primary Completion

June 12, 2017

Study Completion

June 12, 2017

Last Updated

January 29, 2018

Record last verified: 2018-01

Locations

FR(2)