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Dynamic Preload Dependence Indices in Laparoscopic Surgery

Dynamic Preload Dependence Indices in Laparoscopic Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02541656
Acronym
VPP Coelio
Enrollment
40
Registered
2015-09-04
Start date
2015-01-31
Completion date
2016-08-31
Last updated
2018-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Surgery

Keywords

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

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.

Interventions

PROCEDUREStudy 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assess the validity of pulse pressure variation (in %)at Day 0Performing 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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026