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

NCT ID: NCT02812758

Last Updated: 2018-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-05-31

Brief Summary

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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

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Conditions

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Thoracic Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

transthoracic echocardiography

Intervention Type DEVICE

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

Interventions

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transthoracic echocardiography

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel LORNE, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2015_843_0012

Identifier Type: -

Identifier Source: org_study_id

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