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

April 28, 2021 updated by: Marinella Astuto, University of Catania

Perioperative Goal Directed Therapy (PGDT) in Spinal Surgery in the Prone Position: Optimization of Fluid Therapy, Haemodynamic Impact and on Post-operative Complications

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Sicilia
      • Catania, Sicilia, Italy, 95123
        • Gaspare Rodolico Presidium - University Hospital Policlinico-Vittorio Emanuele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency rate of early post-operative complications
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2018

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52/2018/PO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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