NCT06439732

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

May 22, 2024

Last Update Submit

August 21, 2025

Conditions

Hypotension During Surgery

Keywords

Anestethic comsumptionhemodynamic monitoring

Outcome Measures

Primary Outcomes (1)

  • Reduction in Anesthetic consumption

    During surgery

Secondary Outcomes (2)

  • number hypotensive episodes

    during surgery

  • duration hypotensive episodes

    during surgery

Study Arms (2)

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

Acumen IQ cuffDEVICE

Use of Acumen IQ cuff for haemodynamic monitoring

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years of age
  • signature of informed medical consent

You may not qualify if:

  • BMI\> 30
  • eGFR\<30
  • NYHA III-IV
  • severe cardiac valvular diseases
  • absence of informed medical consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario "A. Gemelli" IRCCS

Roma, Roma, 00168, Italy

Location

Study Officials

  • Andrea Russo, MD

    Fondazione Policlinico universitario Agostino Gemelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 22, 2024

First Posted

June 3, 2024

Study Start

July 1, 2024

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations

IT(1)