Interest of the Pleth Variability Index in Neurosurgery

Evaluation of Perioperative Fluid Responsiveness in Neurosurgery: Interest of the Pleth Variability Index

This clinical trial aims to study the interest of the Pleth Variability Index (PVI) to evaluate perioperative fluid responsiveness in neurosurgery in adults.

The main question it aims to answer is:

• Does the Pleth variability index predict fluid responsiveness in neurosurgery? Researchers will compare the Pleth variability index to dela PP to see if it predicts fluid responsiveness in neurosurgery.

Once participants give their consent, they will be randomly assigned to one of two groups. In one group, fluid responsiveness will be monitored using the Pleth Variability Index, while in the other group, it will be monitored using delta PP.

Study Overview

• Status: Completed
• Conditions: Hypovolemia; Intraoperative Monitoring; Fluid Challenge
• Intervention / Treatment: Other: perioperative fluid responsiveness with the Pleth variability index; Other: perioperative fluid responsiveness with delta PP

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia
    • National Institute of Neurologie Mongi Ben-Hamida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients proposed for intracranial surgery
2. Must be aged 18 and over
3. Must be classified as ASA I, ASA II, and ASA III according to the American Society of Anesthesiologists classification

Exclusion Criteria:

1. Non-consenting patients
2. Patients classified ASA IV or higher
3. Cardiac arrhythmia
4. Heart disease with left ventricular ejection fraction less than 45%
5. Obesity with a BMI greater than 40 Kg/m2.
6. Peripheral vascular disease
7. Severe lung disease
8. End-stage renal disease
9. Intraoperative cardiac arrhythmia
10. The occurrence of cardiac arrest
11. The occurrence of hemorrhagic shock
12. Intraoperative use of low tidal volumes or high respiratory rates.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pleth variability index (PVI); Participants will be monitored during the intervention using a Radical-7 Pulse CO-Oximeter to instantly determine the pleth variability index (PVI). If the PVI is more than 14% for at least 5 minutes, 250 ml of gelofusine solution will be given over 10 minutes.	Other: perioperative fluid responsiveness with the Pleth variability index; Perioperative fluid challenge and responsiveness will be based on monitoring the pleth variability index. In fact, volemia will be estimated with the PVI.
Active Comparator: delta PP; Participants will be monitored during the intervention using arterial catheter to instantly determine delta PP. If Delta PP is more than 13% for at least 5 minutes, 250 ml of gelofusine solution will be given over 10 minutes.	Other: perioperative fluid responsiveness with delta PP; fluid challenge and responsiveness during intervention will be based on monitoring delta PP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of PVI in fluid responsiveness in neurosurgery	Investigate the value of the plethysmographic variability index (PVI) in assessing the response to perioperative vascular filling in neurosurgery.	chanfe of PVI value from baseline to a value more than 14% and untill the end of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Amount of fluids administered intraoperatively	during the surgery
Renal, metabolic and hydroelectrolytic repercussions.	up to the first 24 hours postoperatively
Length of postoperative stay	up to hospital discharge, an average of 4 days
Incidence of post-operative complications	up to hospital discharge, an average of 4 days

Collaborators and Investigators

• Sponsor: National Institute of Neurology, Tunisia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): August 19, 2024

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: PVI IN NEUROSURGERY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No