Volume ExpansionREVANINCT04223414
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
An observational study of Volume Expansion and Fluid Responsiveness, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Volume Expansion, Fluid Responsiveness
- What is being tested?
- Analgesia Nociception Index (ANI)
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2020to 25 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient scheduled for neurosurgery
Who may be able to join
- patient older than 18 years
- patient scheduled for neurosurgery in prone position
- patient equipped from an arterial catheter and stroke volume monitoring
- Patient for whom volume expansion is needed.
Who cannot join
- emergency surgery,
- cardiac dysfunction,
- arrythmia,
- beta-blockade therapy,
- pacemaker,
- intracranial hypertension,
- pregnancy,
- dysautonomia
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Volume Expansion, Fluid Responsiveness
- Being tested
- Analgesia Nociception Index (ANI)
- Keywords
- volume expansion, fluid responsiveness, stroke volume, perioperative optimization, analgesia nociception index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia Nociception Index (ANI)Device
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
What is being measured
The primary outcome is the main question the study is designed to answer.
ANI value variation (%) before and after the 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).
Measured: 5 minutes after volume expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start29 Jan 2020
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Volume ExpansionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223414
- Sponsor's protocol ID
- CHUBX 2019/23
- Acronym
- REVANI
- Status last verified
- Jul 2020
- First submitted
- 6 Jan 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Courson H, Chadefaux G, Abel B, Georges D, Verchere E, Biais M. Ability of the Analgesia Nociception Index variations to identify a response to a volume expansion of 250 mL of crystalloids in the operating room (REVANI): a prospective observational study. BMC Anesthesiol. 2023 Jun 21;23(1):218. doi: 10.1186/s12871-023-02181-2.
PubMed 37344801
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04223414
- Acronym / sponsor ID
- REVANI / CHUBX 2019/23
- Conditions
- Volume Expansion, Fluid Responsiveness
- Keywords
- volume expansion, fluid responsiveness, stroke volume, perioperative optimization, analgesia nociception index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient scheduled for neurosurgery
Key inclusion criteria (4 listed)
- patient older than 18 years
- patient scheduled for neurosurgery in prone position
- patient equipped from an arterial catheter and stroke volume monitoring
- Patient for whom volume expansion is needed.
Key exclusion criteria (8 listed)
- emergency surgery,
- cardiac dysfunction,
- arrythmia,
- beta-blockade therapy,
- pacemaker,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Derived from this study: PubMed 37344801de Courson H, Chadefaux G, Abel B, Georges D, Verchere E, Biais M. Ability of the Analgesia Nociception Index variations to identify a response to a volume expansion of 250 mL of crystalloids in the operating room (REVANI): a prospective observational study. BMC Anesthesiol. 2023 Jun 21;23(1):218. doi: 10.1186/s12871-023-02181-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Volume Expansion and Fluid Responsiveness, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ANI value variation (%) before and after the volume expansion (time frame: 5 minutes after volume expansion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04223414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.