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Clinical Trials/NCT02812745
NCT02812745CompletedNot Applicable

Is the Decrease in the Bispectral Index Correlated With a Decrease in Cardiac Output During the Induction of Anaesthesia? A Observational, Single-centre Study

Centre Hospitalier Universitaire, Amiens1 site in 1 country45 target enrollmentStarted: October 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
correlation between variations in the BIS and variations in cardiac output
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Monitoring the bispectral index (BIS) as a peri-operative hemodynamic tool appears to be justified by the agreement between various clinical situations in which BIS monitoring appears to be of value: the prognosis in traumatic head injury, the diagnosis of brain death , and the diagnosis of amniotic fluid embolism. The current controversy concerning the "triple low" state reinforces the need for an accurate study in this field. Furthermore, the recent review by Bidd argues in this sense.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult (over-18) patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth
  • •Good echogenicity
  • •Social security coverage

Exclusion Criteria

  • •Pregnancy
  • •Subjects with black skin (a known technical limitation of plethysmography)
  • •Cardiac arrhythmia
  • •Poor echogenicity
  • •Legal guardianship or incarceration
  • •Complications of anaesthesia during induction (anaphylactic shock, cardiac arrest, arrhythmia, or intubation not possible)

Outcomes

Primary Outcomes

correlation between variations in the BIS and variations in cardiac output

Time Frame: Day 0

as measured by transthoracic echocardiography

Secondary Outcomes

  • correlation between cardiac output and end-tidal carbon dioxide (etCO2) during the induction of anaesthesia.(Day 0)
  • correlation between cardiac output and the perfusion index (PI) during the induction of anaesthesia.(Day 0)
  • correlation between the cardiac output and the value of brain tissue oxygenation (measured by near-infrared spectroscopy (NIRS)) during the induction of anaesthesia(Day 0)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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