CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Plethymographic Variability Index +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04664699
NCT04664699N/ACompleted

Comparison of Standard Monitoring and Plethysmographic Variability Index-Guided Fluid Therapy In Severe Traumatic Brain Injury Patients Scheduled for Emergency Craniotomies: A Randomised Control Trial

Universiti Sains Malaysia·interventional·Posted Dec 11, 2020·Updated Dec 11, 2020

In Brief

A clinical study evaluating Plethymographic Variability Index and Standard Monitoring for Severe Traumatic Brain Injury. Completed, enrolled 64 participants across 1 site.

Detailed Summary

This randomized control trial aims to assess if Plethysmographic Variability Index (PVI)-based therapy improves patient outcome in terms of reduced amount and type of fluid used, lower postoperative lactate levels, lesser increment in sodium and chloride levels, improvement of blood gases in term of pH and BE, and reduction in serum creatinine as compared to standard monitoring based therapy in patients with severe traumatic brain injury.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalaysia
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 11, 2020
Enrollment StartMay 29, 2019
Primary CompletionOct 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.6 years ago

Interventions

Plethymographic Variability Indexdevice

All patients were monitored with the electrocardiogram (ECG), Non Invasive Blood Pressure (NIBP), Pulse oximetry (SpO2) and invasively with an arterial line and central venous line as per institutional protocol. In the PVI group, a pulse oximetry probe was connected to the fourth finger of the hand that did not have an arterial cannulation. The pulse oximeter was connected to a monitor The Massimo ® pulse oximeter (Massimo Corp., Irvine, CA, USA), which has a module for PVI measurements. PVI ≥13% indicates volume responsiveness, and PVI \< 13% indicates adequate volume

Standard Monitoringdevice

All patients were monitored with the electrocardiogram (ECG), Non Invasive Blood Pressure (NIBP), Pulse oximetry (SpO2) and invasively with an arterial line and central venous line as per institutional protocol. Patients were resuscitated according to mean arterial pressure/ heart rate and urine output.