Dynamic Preload Dependence Indices in Laparoscopic Surgery

Laparoscopic Surgery Clinical Trial

— VPP Coelio  

Official title:

Dynamic Preload Dependence Indices in Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541656
• Other study ID #: 2014-879
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Surgery

Intervention

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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the validity of pulse pressure variation (in %)	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 %	at Day 0
Secondary	Threshold value to predict fluid response in laparoscopic conditions.	A fluid challenge is performed after pneumoperitoneum insufflation to assess the fluid response and calculate the threshold value of fluid response.	at Day 0
Secondary	Effect of the pneumoperitoneum insufflation on the preload dependence indices : plethysmographic waveform of pulse oximetry variation .	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.	at Day 0
Secondary	Effect of the pneumoperitoneum insufflation on the preload dependence indices : stroke volume variation .	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.	at Day 0