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

NCT02812745 | Completed

• 1 other identifier: PI2015_843_0011
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery

Keywords

anaesthesia

Outcome Measures

Primary Outcomes (1)

• correlation between variations in the BIS and variations in cardiac output

  as measured by transthoracic echocardiography

  Day 0

Secondary Outcomes (3)

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

  Day 0

• correlation between cardiac output and end-tidal carbon dioxide (etCO2) 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

Study Arms (1)

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

recording of cardiac output DEVICE

patients

other parameters DEVICE

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

patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Study Officials

• Emmanuel LORNE, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 24, 2016
• Study Start: October 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 23, 2018

Record last verified: 2018-04

Locations

FR (1)