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

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.

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Key information

Conditions

Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transthoracic echocardiography

Device

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

Primary outcomes

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

Time frame: Day 0

Secondary outcomes

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

Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: BIS2

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Jun 24, 2016
Registry last updated: Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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