Dynamic Preload Dependence Indices in Laparoscopic Surgery

NCT02541656 | Completed

• 1 other identifier: 2014-879
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Threshold value to predict fluid response in laparoscopic conditions.

  at Day 0

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

  at Day 0

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

  at Day 0

Study Arms (1)

preloaddependence indice after volume expansion in laparoscopy

EXPERIMENTAL

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.

Interventions

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.

preloaddependence indice after volume expansion in laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Need to laparoscopic colectomy or hepatic resection
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69002, France

Location

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: September 4, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

FR (1)