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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04025086

Acronym

PGDT

Enrollment

Registered

2019-07-18

Start date

2018-10-29

Completion date

2020-10-30

Last updated

2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Complication, Intraoperative Hypotension, Pulmonary Complication

Keywords

Spinal Surgery

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Frequency rate of early post-operative complications	7 days

Secondary

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	7 days

Countries

Italy

Outcome results