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CompletedNCT02812745BIS1Updated Apr 23, 2018

Is the Decrease in the Bispectral Index Correlated With a Decrease in Cardiac Output During the Induction of Anaesthesia?

An observational study in Thoracic Surgery, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-23.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Thoracic Surgery

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Keywords

  • anaesthesia
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In context

Cardiac Output, Low

94 studies on the registry are indexed under Cardiac Output, Low; 15 are open to participants now.

This study's enrollment of 45 is below the median of 60 across 45 observational studies indexed under Cardiac Output, Low.

Browse Cardiac Output, Low studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • patients

    patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth * recording of cardiac output * other parameters

    Device: recording of cardiac output · Device: other parameters

Interventions

  • Devicerecording of cardiac output
  • Deviceother parameters

    BIS (bispectral index ), PI (perfusion index ), etCO2 (end-tidal carbon dioxide ), and brain NIRS (near-infrared spectroscopy)

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What researchers measure

Primary outcomes

  1. correlation between variations in the BIS and variations in cardiac output

    as measured by transthoracic echocardiography

    Time frame: Day 0

Secondary outcomes

  1. correlation between cardiac output and the perfusion index (PI) during the induction of anaesthesia.

    measured by transthoracic echocardiography

    Time frame: Day 0

  2. correlation between cardiac output and end-tidal carbon dioxide (etCO2) during the induction of anaesthesia.

    measured by transthoracic echocardiography

    Time frame: Day 0

  3. correlation between the cardiac output and the value of brain tissue oxygenation (measured by near-infrared spectroscopy (NIRS)) during the induction of anaesthesia

    measured by transthoracic echocardiography

    Time frame: Day 0

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Study locations

1 site
  • CHU Amiens
    Amiens, 80054, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02812745
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jun 24, 2016
Start date
Oct 2015
Primary completion
May 2017
Completion
May 2017
Last update
Apr 23, 2018

Study contacts

Emmanuel LORNE, MD, PhD
principal investigator · CHU Amiens
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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