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Dynamic Preload Indicators in Sitting Position

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT02000570
First received: November 27, 2013
Last updated: December 3, 2013
Last verified: November 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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: September 2015
Estimated Primary Completion Date: September 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02000570     History of Changes
Other Study ID Numbers: 2013.813
Study First Received: November 27, 2013
Last Updated: December 3, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on November 20, 2014