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

NCT04025086 | Completed

• 1 other identifier: 52/2018/PO
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraoperative Hypotension; Pulmonary Complication; Cardiovascular Complication

Keywords

Spinal Surgery

Outcome Measures

Primary Outcomes (1)

• Frequency rate of early post-operative complications

  7 days

Secondary Outcomes (1)

• Comparison between the two commonly adopted anesthetic techniques (totally intravenous anesthesia (TIVA / TCI) or balanced anesthesia) in terms of intraoperative management of the patient and post-operative complication

  7 days

Study Arms (2)

Study group

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

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

44 Patients undergoing spinal surgery in prone position at "Gaspare Rodolico Presidium" of Policlinico-Vittorio Emanuele University Hospital of Catania, in which 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) by using a minimally invasive advanced hemodynamic monitoring technology with a special sensor called FloTrac® (Edwards) o a non-invasive monitoring system with Clearsight® sensor (Edwards), is used.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

Gaspare Rodolico Presidium - University Hospital Policlinico-Vittorio Emanuele

Catania, Sicily, 95123, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 18, 2019
• Study Start: October 29, 2018
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

IT (1)