Skip to main content
OpenTrials
Completed

NCT Number: NCT06624891

Interest of the Pleth Variability Index in Neurosurgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intraoperative Monitoring Fluid Challenge Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Neurologie Mongi Ben-Hamida

Tunis, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

perioperative fluid responsiveness with delta PP

Other

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

Primary outcomes

  1. Value of PVI in fluid responsiveness in neurosurgery

    Time frame: 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 outcomes

  1. Amount of fluids administered intraoperatively

    Time frame: during the surgery

  2. Renal, metabolic and hydroelectrolytic repercussions.

    Time frame: up to the first 24 hours postoperatively

  3. Length of postoperative stay

    Time frame: up to hospital discharge, an average of 4 days

  4. Incidence of post-operative complications

    Time frame: up to hospital discharge, an average of 4 days

Sponsors and collaborators

Lead sponsor

National Institute of Neurology, Tunisia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.