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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-29

Study Completion Date

2020-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Intraoperative Hypotension Pulmonary Complication Cardiovascular Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No