Dynamic Preload Indicators in Sitting Position

Not Applicable

Completed

• Conditions: Neurosurgery in Sitting Position
• Interventions: Procedure: Sitting position (neurosurgery)

• Registration Number: NCT02000570
• Lead Sponsor: Hospices Civils de Lyon

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.

Study Timeline

• Study Start: 2013-10-17
• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-04
• Primary Completion: 2018-01-11
• Study Completion: 2018-01-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sitting position	Sitting position (neurosurgery)	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fédération d'anesthésie réanimation Hôpital Pierre Wertheimer; 🇫🇷 Bron, France