Hemodynamic Optimization During Major Urological Surgery (INTAT)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Hemodynamic Instability

Treatments: Device: Ev1000 Clinical Platform from Edwards Lifesciences

Study type: Observational

Funder types: Other

Identifiers

NCT03474224

1822

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

FloTrac patients

Description:

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

Treatment:

Device: Ev1000 Clinical Platform from Edwards Lifesciences