- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06439732
Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal Surgery (HERMES)
August 21, 2025 updated by: RUSSO ANDREA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Roma, Italy, 00168
- Fondazione Policlinico Universitario "A. Gemelli" IRCCS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- over 18 years of age
- signature of informed medical consent
Exclusion Criteria:
- BMI> 30
- eGFR<30
- NYHA III-IV
- severe cardiac valvular diseases
- absence of informed medical consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
In this group we will use a continuous non-invasive hemodynamic monitoring system (Acumen IQ cuff)
|
Use of Acumen IQ cuff for haemodynamic monitoring
|
|
No Intervention: Control
In this group we will use the oscillometric non-invasive blood pressure monitoring system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction in Anesthetic consumption
Time Frame: During surgery
|
During surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number hypotensive episodes
Time Frame: during surgery
|
during surgery
|
|
duration hypotensive episodes
Time Frame: during surgery
|
during surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrea Russo, MD, Fondazione Policlinico Universitario Agostino Gemelli
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2024
Primary Completion (Actual)
May 1, 2025
Study Completion (Actual)
June 1, 2025
Study Registration Dates
First Submitted
May 22, 2024
First Submitted That Met QC Criteria
May 27, 2024
First Posted (Actual)
June 3, 2024
Study Record Updates
Last Update Posted (Actual)
August 22, 2025
Last Update Submitted That Met QC Criteria
August 21, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6704
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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