Dynamic Preload Indicators in Sitting Position

NCT ID: NCT02000570

Last Updated: 2018-09-05

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

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-17

Study Completion Date

2018-01-11

Brief Summary

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Intraoperative optimization of cardiac output using goal directed fluid challenge is associated with better outcome. Dynamic preload dependence indicators are well validated during surgery in supine position. Positioning from supine to sitting position under anesthesia is responsible of several hemodynamic changes. Predictability and cut-off values of dynamic preload dependence indicators during surgery in sitting position are unknown. The objective of this prospective study is to evaluate ability of three dynamic preload dependence indicators, i.e. PPV (Pulse Pressure Variation), SVV (Stroke Volume Variation) and PVI (Plethysmographic Variability Index), during neurosurgery in sitting position.

Detailed Description

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The primary objective is to determine PPV, SVV and PVI thresholds for which patients respond to fluid challenge in sitting position.

The secondary objectives are to determine variations of PPV, SVV and PVI measures before and after positioning in sitting position, and to compare these values to each other.

Conditions

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Neurosurgery in Sitting Position

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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sitting position

Group Type EXPERIMENTAL

Sitting position (neurosurgery)

Intervention Type PROCEDURE

Interventions

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Sitting position (neurosurgery)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* neurosurgery in sitting position
* age \> 18

Exclusion Criteria

* arrhythmias
* severe heart failure
* severe lung disease
* contraindications to esophageal Doppler monitoring probe insertion (i.e. esophageal weakness)
* renal failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fédération d'anesthésie réanimation Hôpital Pierre Wertheimer

Bron, , France

Site Status

Countries

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France

Other Identifiers

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2013-A00937-38

Identifier Type: OTHER

Identifier Source: secondary_id

2013.813

Identifier Type: -

Identifier Source: org_study_id

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