Clinical Trials Logo
  1. Home
  2. Fluid Responsiveness
  3. NCT04223414

Ability of Changes in Analgesia Nociception Index to Assess the Stroke Volume Effects of a Volume Expansion of 250ml of Crystalloid in the Operating Room — REVANI  

Fluid Responsiveness Clinical Trial

Official title:
Ability of Changes in Analgesia Nociception Index to Assess the Stroke Volume Effects of a Volume Expansion of 250ml of Crystalloid in the Operating Room. REVANI Trial

Clinical Trial Summary

Volume expansion is the cornerstone of perioperative hemodynamic optimization. The main objective of volume expansion is to increase and maximize stroke volume. Hemodynamic changes have an impact on the autonomic nervous system. The analysis of heart rate variability allows an exploration of the autonomic nervous system and could therefore provide information on the effect of volume expansion. The Analgesia Nociception Index (ANI) is an analgesia monitor based on the concept of heart rate variability. By deviating from its original use, the investigators wish to evaluate the ability of ANI to identify a response to volume expansion.

Clinical Trial Description

Perioperative optimization is based on volume maximization using volume expansion. The main objective of volume expansion is to increase stroke volume. The Franck-Starling curve is schematically divided into two portions: a vertical portion which mean that an increase in preload secondary to volume expansion will induce an increase in stroke volume; and a flat portion where volume expansion will not induce an increase in stroke volume. Perioperative optimization is based on stroke volume maximization using volume expansion.

In case of hypovolemia, there is a compensatory sympathetic stimulation with parasympathetic withdrawal. Volume expansion will lead to an increase in venous return and therefore in cardiac output, which will result in a decrease in sympathetic tone. The autonomic nervous system is therefore directly affected by these load changes. The analysis of heart rate variability, which has been studied for several years in various setting, allows the assessment of autonomic nervous system, through monitoring of the electrocardiogram. Experimental and clinical studies report the ability of variations in heart rate variability to detect a situation of hypovolemia. In anaesthesia, heart rate variability is used to evaluate the nociception-antinociception balance. Indeed, any nociceptive stimulation leads to an increase in sympathetic tone. MetroDoloris has developed a non-invasive monitor that provides an index, the Analgesia Nociception Index (ANI), to evaluate the nociception-antinociception balance by analysing the autonomic nervous system.

In this study, the original use of ANI will be diverted from its initial use, to analyse the autonomic nervous system's response to volume expansion. Thus, the aim of the present study is to determine whether a change in Analgesia Nociception Index can track the stroke volume effects of a volume expansion using 250ml of crystalloid in the operating room.

The follow up will be restricted to the duration of surgical intervention. The last data will be collected 5 minutes after the end of volume expansion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04223414
Study type Observational
Source University Hospital, Bordeaux
Contact
Status Completed
Phase
Start date January 29, 2020
Completion date June 25, 2020
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01941472 - Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness N/A
Terminated NCT03208023 - RESIPI for Reducing Perioperative Major Adverse Cardiac Events N/A
Completed NCT03713008 - Assessment Of Carotid Flow During General Anesthesia N/A
Completed NCT02277353 - Evaluation of SVV From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery N/A
Not yet recruiting NCT04092036 - Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness
Completed NCT04060069 - Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness
Recruiting NCT05153837 - Effect of Oral Water in Healthy Volunteers on Cardiac Output, Regional Flow and Microcirculation in Healthy Volunteers N/A
Not yet recruiting NCT06143111 - A Comparison of Thoracic Electrical Bioimpedance and FloTrac/Vigileo N/A
Not yet recruiting NCT05601622 - RPVI for Fluid Responsiveness in Children N/A
Completed NCT04889807 - Study of End Tidal Carbon Dioxide (EtCO2) Variation After an End- Expiratory Occlusion Test as a Predictive Criteria of Fluid Responsiveness in Mechanically Ventilated Patients
Recruiting NCT04186416 - Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients
Completed NCT01996956 - Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery N/A
Enrolling by invitation NCT04388995 - SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia N/A
Not yet recruiting NCT04574011 - Fluid Responsiveness in Spontaneously Ventilating Patient N/A
Completed NCT01821742 - Echocardiography in Kids Intensive Care Decision Support
Completed NCT04802668 - Factors Influencing of Pulse Pressure Variation (PPV)
Not yet recruiting NCT06254456 - Fluid Responsiveness in Prone Patients N/A
Completed NCT02789124 - Diagnostic Value of Passive Leg Raise Induced Changes in Carotid Artery Flow Time to Predict Fluid Responsiveness in Critically Ill Patients N/A
Withdrawn NCT01898975 - A Gray Zone Approach to Stroke Volume Variation Derived From NICOM N/A
Completed NCT02040948 - Accuracy of Pulse Pressure Variation and of Pleth Variability Index to Predict the Response to a Fluid Challenge N/A