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Completed

NCT Number: NCT02812745

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

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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Key information

Conditions

Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Sepsis
  • Poor echogenicity
  • Legal guardianship or incarceration
  • Complications of anaesthesia during induction (anaphylactic shock, cardiac arrest, arrhythmia, or intubation not possible)

Treatment and study plan

recording of cardiac output

Device

other parameters

Device

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

Primary outcomes

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

    Time frame: Day 0

    as measured by transthoracic echocardiography

Secondary outcomes

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

    Time frame: Day 0

    measured by transthoracic echocardiography

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

    Time frame: Day 0

    measured by transthoracic echocardiography

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

    Time frame: Day 0

    measured by transthoracic echocardiography

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: BIS1

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 24, 2016
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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