Perioperative Goal Directed Therapy (PGDT) in Spinal Surgery in the Prone Position

University of Catania

Status: Completed

Conditions: Intraoperative Hypotension; Cardiovascular Complication; Pulmonary Complication

Study type: Observational

Funder types: Other

Identifiers

NCT04025086

52/2018/PO

Details and patient eligibility

About

This study aims at evaluating if a specific protocol, that can be framed in the innovative concept of Perioperative Goal Directed Therapy (PGDT), based on the evaluation of the Stroke Volume Variation (SVV) - a parameter deriving from the adoption of a minimally invasive advanced hemodynamic monitoring technology with a special sensor called FloTrac® (Edwards) or of a non-invasive monitoring system with the Clearsight® sensor (Edwards) - is able to guarantee a greater precision in the intraoperative management of patients undergoing spinal surgery in prone position.

Enrollment: 88 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18-80 years
• American Society of Anesthesiologists(ASA) Classification I-II-III
• Minor and major spinal surgery
• Prone position
• Sinus rhythm
• Absence of atrial fibrillation. or severe arrhythmia
• Informed consent

Exclusion criteria

• Absence of informed consent
• Age less than 18 or older than 80 years
• Cardiac rhythm abnormalities: atrial fibrillation and / or severe arrhythmia

Trial design

88 participants in 2 patient groups

Study group

Description:

44 patient undergoing spinal surgery in prone position at "Gaspare Rodolico Presidium", in which the new "Perioperative Goal Directed Therapy" protocol has been used

Control group

Description:

44 patients who underwent spinal surgery in the period January 2016 - December 2017, in which was not used a Perioperative Goal Directed Therapy approach but a classical hemodynamic monitoring, according to the recommendations of good clinical practice and the international guidelines.