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

Thoracic Surgery Clinical Trial

— BIS1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812745
• Other study ID #: PI2015_843_0011
• Status: Completed
• First received: June 20, 2016
• Last updated: April 20, 2018
• Start date: October 2015
• Est. completion date: May 2017

Study information

• Verified date: April 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Output, Low
• Thoracic Surgery

Intervention

Device:
• recording of cardiac output

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between variations in the BIS and variations in cardiac output	as measured by transthoracic echocardiography	Day 0
Secondary	correlation between cardiac output and the perfusion index (PI) during the induction of anaesthesia.	measured by transthoracic echocardiography	Day 0
Secondary	correlation between cardiac output and end-tidal carbon dioxide (etCO2) during the induction of anaesthesia.	measured by transthoracic echocardiography	Day 0
Secondary	correlation between the cardiac output and the value of brain tissue oxygenation (measured by near-infrared spectroscopy (NIRS)) during the induction of anaesthesia	measured by transthoracic echocardiography	Day 0