Interest of the Pleth Variability Index in Neurosurgery

NCT06624891 | Completed

• 1 other identifier: PVI IN NEUROSURGERY
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Monitoring; Hypovolemia; Fluid Challenge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

pleth variability index (PVI)

EXPERIMENTAL

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

delta PP

ACTIVE COMPARATOR

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

Interventions

perioperative fluid responsiveness with the Pleth variability index OTHER

Perioperative fluid challenge and responsiveness will be based on monitoring the pleth variability index. In fact, volemia will be estimated with the PVI.

pleth variability index (PVI)

perioperative fluid responsiveness with delta PP OTHER

fluid challenge and responsiveness during intervention will be based on monitoring delta PP.

delta PP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Neurology, Tunisia: lead

Study Sites (1)

National Institute of Neurologie Mongi Ben-Hamida

Tunis, Tunisia

Location

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: university hospital assistant

Model Details: prospective comparative randomized clinical trial

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: October 3, 2024
• Study Start: March 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 19, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-08

Locations

TU (1)