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

Completed

• Conditions: Thoracic Surgery
• Interventions: Device: transthoracic echocardiography

• Registration Number: NCT02812758
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-22
• 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

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients	transthoracic echocardiography	All sedated, intubated, mechanically ventilated adult patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI) transthoracic echocardiography

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France