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Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence? (BIS2)

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ClinicalTrials.gov Identifier: NCT02812758
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Thoracic Surgery Device: transthoracic echocardiography

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence? An Observational, Single-centre Pilot Study
Study Start Date : December 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Group/Cohort Intervention/treatment
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
recording of data on cardiac output measured non-invasively by transthoracic echocardiography, including the SVV




Primary Outcome Measures :
  1. Values of the dynamic indices (SVV, PPV and PVI) at different sedation levels (as evaluated by the BIS) [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812758


Locations
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France
CHU Amiens
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Emmanuel LORNE, Md, PhD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02812758    
Other Study ID Numbers: PI2015_843_0012
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
sedation depth
indices of preload dependence