Dynamic Preload Indicators in Sitting Position

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02000570

Enrollment

Registered

2013-12-04

Start date

2013-10-17

Completion date

2018-01-11

Last updated

2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurosurgery in Sitting Position

Keywords

sitting position, PPV, SVV, PVI, fluid challenge, preload indicators

Brief summary

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.

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.

Interventions

PROCEDURESitting position (neurosurgery)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PPV (Pulse pressure variation)	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)	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)	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026