Hypotension During SurgeryHERMESNCT06439732
Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal Surgery
A study testing Acumen IQ cuff in people with Hypotension During Surgery, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
In this study investigators will study the association between the use of an hemodynamic monitoring system and the anesthetic consumption in patients following major abdominal surgery. Investigators will randomise patients for a control group and an intervention group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- Acumen IQ cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2024to 1 Jun 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age
- signature of informed medical consent
Who cannot join
- BMI> 30
- eGFR<30
- NYHA III-IV
- severe cardiac valvular diseases
- absence of informed medical consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario "A. Gemelli" IRCCS
Roma, Roma, 00168
About this study
In this study investigators will study the association between the use of an hemodynamic monitoring system and the anesthetic consumption in patients following major abdominal surgery. Investigators will randomise patients for a control group and an intervention group. Patients belonging to intervention group will be monitored with a non-invasively continue system (Acumen IQ cuff sensor), while the control group will be monitored with a non-invasive intermittent pressure system. The total amount of mL of Sevoflurane will be registered in both groups and the difference will be considered as the aim of our study
- Conditions
- Hypotension During Surgery
- Being tested
- Acumen IQ cuff
- Keywords
- Anestethic comsumption, hemodynamic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acumen IQ cuffDevice
Use of Acumen IQ cuff for haemodynamic monitoring
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In this group we will use a continuous non-invasive hemodynamic monitoring system (Acumen IQ cuff) Receives: Device: Acumen IQ cuff |
| Control | No intervention | In this group we will use the oscillometric non-invasive blood pressure monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Anesthetic consumption
Measured: During surgery
Secondary outcomes (2)
number hypotensive episodes
Measured: during surgery
duration hypotensive episodes
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Jul 2024
- Primary completion1 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUSSO ANDREA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Andrea Russo, MD, Principal investigator, Fondazione Policlinico universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439732
- Sponsor's protocol ID
- 6704
- Acronym
- HERMES
- Status last verified
- Aug 2025
- First submitted
- 22 May 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06439732
- Acronym / sponsor ID
- HERMES / 6704
- Conditions
- Hypotension During Surgery
- Keywords
- Anestethic comsumption, hemodynamic monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 3 Jun 2024 (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.
In this study investigators will study the association between the use of an hemodynamic monitoring system and the anesthetic consumption in patients following major abdominal surgery. Investigators will randomise patients for a control group and an intervention group. Patients belonging to intervention group will be monitored with a non-invasively continue system (Acumen IQ cuff sensor), while the control group will be monitored with a non-invasive intermittent pressure system. The total amount of mL of Sevoflurane will be registered in both groups and the difference will be considered as the aim of our study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Acumen IQ cuffIn this group we will use a continuous non-invasive hemodynamic monitoring system (Acumen IQ cuff) |
| Control | No intervention | –In this group we will use the oscillometric non-invasive blood pressure monitoring system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years of age
- signature of informed medical consent
Key exclusion criteria (5 listed)
- BMI> 30
- eGFR<30
- NYHA III-IV
- severe cardiac valvular diseases
- absence of informed medical consent
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 |
|---|---|---|
| Acumen IQ cuffUse of Acumen IQ cuff for haemodynamic monitoring | Device | Intervention |
Primary outcome
Reduction in Anesthetic consumption
Time frame: During surgery
2 secondary outcomes
number hypotensive episodes
Time frame: during surgery
duration hypotensive episodes
Time frame: during surgery
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 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Andrea Russo, MD principal investigator
Fondazione Policlinico universitario Agostino Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acumen IQ cuff in people with Hypotension During Surgery, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 2 inclusion and 5 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 22 Aug 2025. 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 Italy. 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?
Reduction in Anesthetic consumption (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2025.