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

April 20, 2018 updated by: Centre Hospitalier Universitaire, Amiens

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between variations in the BIS and variations in cardiac output
Time Frame: Day 0
as measured by transthoracic echocardiography
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between cardiac output and the perfusion index (PI) during the induction of anaesthesia.
Time Frame: Day 0
measured by transthoracic echocardiography
Day 0
correlation between cardiac output and end-tidal carbon dioxide (etCO2) during the induction of anaesthesia.
Time Frame: Day 0
measured by transthoracic echocardiography
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
Time Frame: Day 0
measured by transthoracic echocardiography
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 20, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2015_843_0011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thoracic Surgery

Clinical Trials on recording of cardiac output

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe