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

NCT02812758 | Completed

• 1 other identifier: PI2015_843_0012
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery

Keywords

sedation depth; indices of preload dependence

Outcome Measures

Primary Outcomes (1)

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

  Day 0

Secondary Outcomes (1)

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

  Day 0

Study Arms (1)

patients

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

Device: transthoracic echocardiography

Interventions

transthoracic echocardiography DEVICE

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

patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Emmanuel LORNE, Md, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 24, 2016
• Study Start: December 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 23, 2018

Record last verified: 2018-04

Locations

FR (1)