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

Thoracic Surgery Clinical Trial

— BIS2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812758
• Other study ID #: PI2015_843_0012
• Status: Completed
• First received: June 20, 2016
• Last updated: April 20, 2018
• Start date: December 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

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.

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:

• 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

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

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

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	Values of the dynamic indices (SVV, PPV and PVI) at different sedation levels (as evaluated by the BIS)		Day 0
Secondary	The proportion of patients that change their preload dependence status during a change in sedation depth (as evaluated by the BIS).		Day 0