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)
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|ClinicalTrials.gov Identifier: NCT04223414|
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment|
|Volume Expansion Fluid Responsiveness||Device: Analgesia Nociception Index (ANI)|
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 Type :||Observational|
|Estimated Enrollment :||66 participants|
|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|
|Actual Study Start Date :||January 29, 2020|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
- Device: Analgesia Nociception Index (ANI)
ANI will be used to analyse the autonomic nervous system's response to volume expansion.
ANI will be assessed during surgery, before during and after the volume expansion
- ANI value variation (%) before and after the volume expansion [ Time Frame: 5 minutes after volume expansion ]Changes in the analgesia nociception index during a volume expansion of 250 mL crystalloid during 10 minutes in patients who responded to volume expansion (stroke volume increase by 10% or more after volume expansion) and in patients who did not respond to volume expansion (stroke volume increase less than 10% after volume expansion).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04223414
|Contact: Mathieu BIAIS, Pr||0557821019 ext +firstname.lastname@example.org|
|CHU de Bordeaux||Recruiting|
|Bordeaux, France, 33076|
|Contact: Mathieu BIAIS, Pr 05 57 82 10 19 email@example.com|