VPP Coelio: Dynamic Preload Dependence Indices in Laparoscopic Surgery

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT02541656

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Surgery	Procedure: Study of preload dependence indices after volume expansion in laparoscopy with Saldinger technique.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Dynamic Preload Dependence Indices in Laparoscopic Surgery

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: 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.

Arm

Intervention/Treatment

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospices Civils de Lyon	Lyon		France	69002

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT02541656

Other Study ID Numbers:

2014-879

First Posted:

Sep 4, 2015

Last Update Posted:

Dec 13, 2018

Last Verified:

Dec 1, 2018

Keywords provided by Hospices Civils de Lyon

Preload dependence indices

pulse pressure variation

plethysmographic waveform of pulse oximetry variation

stroke volume variation

laparoscopy

pneumoperitoneum

Study Results

No Results Posted as of Dec 13, 2018