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OpenTrials
Completed

NCT Number: NCT02000570

Dynamic Preload Indicators 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.

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Key information

Conditions

Neurosurgery in Sitting Position

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fédération d'anesthésie réanimation Hôpital Pierre Wertheimer

Bron, 69500, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitting position (neurosurgery)

Procedure

Primary outcomes

  1. 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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 4, 2013
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.