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Is the Decrease in the Bispectral Index Correlated With a Decrease in Cardiac Output During the Induction of Anaesthesia? (BIS1)

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ClinicalTrials.gov Identifier: NCT02812745
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment
Thoracic Surgery Device: recording of cardiac output Device: other parameters

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : October 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. correlation between variations in the BIS and variations in cardiac output [ Time Frame: Day 0 ]
    as measured by transthoracic echocardiography


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812745


Locations
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France
CHU Amiens
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Emmanuel LORNE, MD, PhD CHU Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02812745     History of Changes
Other Study ID Numbers: PI2015_843_0011
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
anaesthesia
Additional relevant MeSH terms:
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Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs