Dynamic Preload Dependence Indices in Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Laparoscopic Surgery
• Interventions: Procedure: Study of preload dependence indices after volume expansion in laparoscopy with Saldinger technique.

• Registration Number: NCT02541656
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-04
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Need to laparoscopic colectomy or hepatic resection
• Written informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
preloaddependence indice after volume expansion in laparoscopy	Study of preload dependence indices after volume expansion in laparoscopy with Saldinger technique.	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.

Primary Outcome Measures

Name	Time	Method
Assess the validity of pulse pressure variation (in %)	at Day 0	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 %

Secondary Outcome Measures

Name	Time	Method
Effect of the pneumoperitoneum insufflation on the preload dependence indices : plethysmographic waveform of pulse oximetry variation .	at Day 0	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.
Effect of the pneumoperitoneum insufflation on the preload dependence indices : stroke volume variation .	at Day 0	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.
Threshold value to predict fluid response in laparoscopic conditions.	at Day 0	A fluid challenge is performed after pneumoperitoneum insufflation to assess the fluid response and calculate the threshold value of fluid response.

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France