Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence?

Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence? An Observational, Single-centre Pilot Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02812758

Acronym

BIS2

Enrollment

Registered

2016-06-24

Start date

2015-12-31

Completion date

2017-05-31

Last updated

2018-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Surgery

Keywords

sedation depth, indices of preload dependence

Brief summary

Dynamic indices of preload dependence (such as stroke volume variability -SVV , pulse pressure variability - PPV and plethysmograph variability index - PVI ) are reportedly predictive of the response to vascular filling in sedated, mechanically ventilated patients. However, the influence of the sedation depth on these dynamic indices has never been evaluated.

Interventions

DEVICEtransthoracic echocardiography

recording of data on cardiac output measured non-invasively by transthoracic echocardiography, including the SVV

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* All sedated, intubated, mechanically ventilated adult (over-18) patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI) * Good echogenicity * Social security coverage

Exclusion criteria

* Pregnancy, legal guardianship * Subjects with black skin (a known technical limitation of plethysmography) * Cardiac arrhythmia * Sepsis * Poor echogenicity

Design outcomes

Primary

Measure	Time frame
Values of the dynamic indices (SVV, PPV and PVI) at different sedation levels (as evaluated by the BIS)	Day 0

Secondary

Measure	Time frame
The proportion of patients that change their preload dependence status during a change in sedation depth (as evaluated by the BIS).	Day 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026