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Dynamic Preload Dependence Indices in Laparoscopic Surgery

NCT ID: NCT02541656

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-08-31

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.

Detailed Description

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Conditions

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Laparoscopic Surgery

Keywords

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Preload dependence indices pulse pressure variation plethysmographic waveform of pulse oximetry variation stroke volume variation laparoscopy pneumoperitoneum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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preloaddependence indice after volume expansion in laparoscopy

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.

Group Type EXPERIMENTAL

Study of preload dependence indices after volume expansion in laparoscopy with Saldinger technique.

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2014-879

Identifier Type: -

Identifier Source: org_study_id