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

Completed

• Conditions: Thoracic Surgery
• Interventions: Device: recording of cardiac output; Device: other parameters

• Registration Number: NCT02812745
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-24
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-20
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
correlation between variations in the BIS and variations in cardiac output	Day 0	as measured by transthoracic echocardiography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France