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Dynamic Preload Indicators in Sitting Position

This study is currently recruiting participants.
Verified August 2017 by Hospices Civils de Lyon
Sponsor:
ClinicalTrials.gov Identifier:
NCT02000570
First Posted: December 4, 2013
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
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.

Condition Intervention
Neurosurgery in Sitting Position Procedure: Sitting position (neurosurgery)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Abilities of Dynamic Preload Dependence Indicators to Predict Fluid Responsiveness During Neurosurgery in Sitting Position

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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.


  • 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.


  • 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.



Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sitting position Procedure: Sitting position (neurosurgery)

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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT02000570


Contacts
Contact: Lionel BAPTESTE, MD +33 4 72 35 79 42 lionel.bapteste@chu-lyon.fr

Locations
France
Fédération d'anesthésie réanimation Hôpital Pierre Wertheimer Recruiting
Bron, France, 69500
Contact: Lionel BAPTESTE, MD    +33 4 72 35 79 42    lionel.bapteste@chu-lyon.fr   
Principal Investigator: Lionel BAPTESTE, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02000570     History of Changes
Other Study ID Numbers: 2013.813
First Submitted: November 27, 2013
First Posted: December 4, 2013
Last Update Posted: August 9, 2017
Last Verified: August 2017

Keywords provided by Hospices Civils de Lyon:
sitting position
PPV
SVV
PVI
fluid challenge
preload indicators