Impact of Using an Hemodynamic Monitoring System on Anest... | NCT06439732

Studies
Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal Surgery

NCT06439732

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Completed

Last Update Posted

Aug 22, 2025Actual

Enrollment

84Actual

Phase

Not Applicable

Conditions

Hypotension During Surgery

Interventions

Acumen IQ cuff

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Actual

Primary Completion Date

May 1, 2025Actual

Completion Date

Jun 1, 2025Actual

First Submitted Date

May 22, 2024

First Submission Date that Met QC Criteria

May 27, 2024

First Posted Date

Jun 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2025

Last Update Posted Date

Aug 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

RUSSO ANDREA, principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	In this group we will use a continuous non-invasive hemodynamic monitoring system (Acumen IQ cuff)	Device: Acumen IQ cuff
Control	No Intervention	In this group we will use the oscillometric non-invasive blood pressure monitoring system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acumen IQ cuff	Device	Use of Acumen IQ cuff for haemodynamic monitoring	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in Anesthetic consumption		During surgery

Secondary Outcomes

Measure	Description	Time Frame
number hypotensive episodes		during surgery
duration hypotensive episodes		during surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea Russo, MD	Fondazione Policlinico universitario Agostino Gemelli	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario "A. Gemelli" IRCCS		Roma	Roma	00168	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided