Dynamic Preload Indicators in Sitting Position

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT02000570

Collaborator

(none)

Enrollment

Location

Arm

50.8

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurosurgery in Sitting Position	Procedure: Sitting position (neurosurgery)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 17, 2013

Actual Primary Completion Date :

Jan 11, 2018

Actual Study Completion Date :

Jan 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sitting position	Procedure: Sitting position (neurosurgery)

Arm

Intervention/Treatment

Experimental: sitting position

Procedure: Sitting position (neurosurgery)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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