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

November 27, 2013
December 3, 2013
October 2013
September 2015   (final data collection date for primary outcome measure)
  • 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.

Same as current
Complete list of historical versions of study NCT02000570 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dynamic Preload Indicators in Sitting Position
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Neurosurgery in Sitting Position
Procedure: Sitting position (neurosurgery)
Experimental: sitting position
Intervention: Procedure: Sitting position (neurosurgery)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Lionel BAPTESTE, MD +33 4 72 35 79 42 lionel.bapteste@chu-lyon.fr
France
 
NCT02000570
2013.813
No
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Not Provided
Hospices Civils de Lyon
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP