Dynamic Preload Indicators in Sitting Position

September 4, 2018 updated by: Hospices Civils de Lyon

Abilities of Dynamic Preload Dependence Indicators to Predict Fluid Responsiveness During Neurosurgery in Sitting Position

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Fédération d'anesthésie réanimation Hôpital Pierre Wertheimer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: sitting position
Procedure: Sitting position (neurosurgery)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPV (Pulse pressure variation)
Time Frame: 3 minutes before and after fluid challenge in sitting position

PPV is derived from arterial pressure waveforms and is displayed in real -time on Intellivue MP70 Philips monitors.

Value will be recorded before fluid challenge. Responders will be assessed by esophageal Doppler.
3 minutes before and after fluid challenge in sitting position
SVV (Stroke volume variation)
Time Frame: 3 minutes before and after positioning in sitting position

SVV is derived from arterial pressure waveforms and is displayed in real -time on Vigileo Edwards Lifesciences monitors.

Value will be recorded before fluid challenge. Responders will be assessed by esophageal Doppler.
3 minutes before and after positioning in sitting position
PVI (Plethysmographic variability index)
Time Frame: 3 minutes before and after positioning in sitting position

PVI is derived from plethysmography waveforms and is displayed in real-time on Radical 7 Masimo monitors.

Value of each indicator will be recorded before fluid challenge. Responders will be assessed by esophageal Doppler.
3 minutes before and after positioning in sitting position

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 17, 2013

Primary Completion (ACTUAL)

January 11, 2018

Study Completion (ACTUAL)

January 11, 2018

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (ESTIMATE)

December 4, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013.813
  • 2013-A00937-38 (OTHER: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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