Interest of the Pleth Variability Index in Neurosurgery

Not Applicable

Completed

• Conditions: Intraoperative Monitoring; Hypovolemia; Fluid Challenge

• Registration Number: NCT06624891
• Lead Sponsor: National Institute of Neurology, Tunisia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2024-06-30
• Status Verified: 2024-08
• Study Completion: 2024-08-19
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Institute of Neurologie Mongi Ben-Hamida; 🇹🇳 Tunis, Tunisia