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Completed

NCT Number: NCT02541656

Dynamic Preload Dependence Indices in Laparoscopic Surgery

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.

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Key information

Conditions

Laparoscopic Surgery Digestive System Diseases Peritoneal Diseases Pneumoperitoneum

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Lyon, 69002, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Assess the validity of pulse pressure variation (in %)

    Time frame: 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 outcomes

  1. Threshold value to predict fluid response in laparoscopic conditions.

    Time frame: at Day 0

    A fluid challenge is performed after pneumoperitoneum insufflation to assess the fluid response and calculate the threshold value of fluid response.

  2. Effect of the pneumoperitoneum insufflation on the preload dependence indices : plethysmographic waveform of pulse oximetry variation .

    Time frame: 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.

  3. Effect of the pneumoperitoneum insufflation on the preload dependence indices : stroke volume variation .

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: VPP Coelio

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 4, 2015
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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