Dynamic Preload Dependence Indices in Laparoscopic Surgery

Study Overview
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Brief Summary
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A goal-directed fluid management is definitely beneficial in high risk surgery. The fluid administration can be directed by cardiac output monitoring which evaluate the response to repeated fluid challenge or by preload dependence indices. These indices are not well validated in laparoscopic surgery while pneumoperitoneum can alter venous return or pulmonary compliance. The aim of the study is to study the validity of pulse pressure variation to predict fluid response under laparoscopic conditions and to describe the effect of the pneumoperitoneum on the dynamic preload indicators, i.e. the pulse pressure variation, the plethysmographic waveform of pulse oximetry variation and the stroke volume variation.

Official Title
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Dynamic Preload Dependence Indices in Laparoscopic Surgery

Conditions
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Laparoscopic Surgery

Intervention / Treatment
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* Procedure: Study of preload dependence indices after volume expansion in laparoscopy with Saldinger technique.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Need to laparoscopic colectomy or hepatic resection Written informed consent Exclusion Criteria: Cardiac arrhythmia Esophageal and cervical pathologies Radial artery Allen test negative Allergy to anesthesic treatment, to egg or soja Severe kidney failure (estimated glomerular filtration rate < 30 ml/min) Age < 18 years old Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preloaddependence indice after volume expansion in laparoscopy<br>The measurements of pulse pressure variation, plethysmographic waveform of pulse oximetry variation and stroke volume variation will be performed before pneumoperitoneum at the beginning of the surgery, and will be repeated after pneumoperitoneum insufflation applying each time modification of preload conditions (applying reverse Trendelenburg position followed by Trendelenburg position). The responses will be appreciated by the measurements of the stroke volume. | Procedure: Study of preload dependence indices after volume expansion in laparoscopy with Saldinger technique.<br>* The measurements of pulse pressure variation, plethysmographic waveform of pulse oximetry variation and stroke volume variation will be performed before pneumoperitoneum at the beginning of the surgery, and will be repeated after pneumoperitoneum insufflation applying each time modification of preload conditions (applying reverse Trendelenburg position followed by Trendelenburg position). The responses will be appreciated by the measurements of the stroke volume.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the validity of pulse pressure variation (in %) | Performing a fluid challenge after pneumoperitoneum insufflation, the association between pulse pressure variation value and stroke volume variation will be performed. Responder patients are defined by stroke volume augmentation > 15 % | at Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Threshold value to predict fluid response in laparoscopic conditions. | A fluid challenge is performed after pneumoperitoneum insufflation to assess the fluid response and calculate the threshold value of fluid response. | at Day 0 | 
| Effect of the pneumoperitoneum insufflation on the preload dependence indices : plethysmographic waveform of pulse oximetry variation . | The measures are performed after applying patient positioning which modify preload conditions. These measures are repeated before and after pneumoperitoneum insufflation and the values of each indices are compared. | at Day 0 | 
| Effect of the pneumoperitoneum insufflation on the preload dependence indices : stroke volume variation . | The measures are performed after applying patient positioning which modify preload conditions. These measures are repeated before and after pneumoperitoneum insufflation and the values of each indices are compared. | at Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preload dependence indices, pulse pressure variation, plethysmographic waveform of pulse oximetry variation, stroke volume variation, laparoscopy, pneumoperitoneum