Hemodynamic Optimization During Major Urological Surgery

NCT ID: NCT03474224

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-05
• Study Completion Date: 2020-07-28

Brief Summary

In this prospective observational study investigators aim to seek for any possible correlation between the venous to arterial carbon dioxide difference (pCO2 gap) at the end of surgery and the percentage of time spent above a predefined threshold of stroke volume (SV) andn mean arterial pressure (MAP).

Detailed Description

During major urological surgery (i.e. cistectomy) investigators will use a minimally invasive hemodynamic monitoring system (Flotrac - Vigileo, Edwards ) to guide fluid therapy and vasopressors administration. More specifically stroke volume target will be defined as the maximum SV after a series of fluid boluses, with a 10% tolerance. MAP was considered adequate if above 65 mmHg. After the induction of anesthesia, then each hour during surgery until the end of surgical procedure investigators will assess the time of adherence to the hemodynamic protocol (in terms of both SV and MAP) and the correspondent pCO2 gap. Investigators expect to find an inverse proportionality between the two parameters explored.

Conditions

Hemodynamic Instability

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

FloTrac patients

patients belong to this group will be managed with a stroke volume target hemodynamic protocol

Ev1000 Clinical Platform from Edwards Lifesciences

Intervention Type: DEVICE

The EV1000 Hemodynamic monitoring platform will be used to guide fluid administration following a volume-based parameter such the stroke volume.

Interventions

Ev1000 Clinical Platform from Edwards Lifesciences

The EV1000 Hemodynamic monitoring platform will be used to guide fluid administration following a volume-based parameter such the stroke volume.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients scheduled for major urological surgery
• ASA 1-2-3

Exclusion Criteria

• pregnancy
• obesity with a BMI > 35
• controindications to central venous catheter positioning
• end-stage renal disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

RUSSO ANDREA

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Russo, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology

Locations

Andrea Russo

Rome, , Italy

Countries

Italy

Other Identifiers

1822

Identifier Type: -

Identifier Source: org_study_id