Randomized Control Trial to Compare Standard Monitoring and Plethysmographic Variability Index-Guided Fluid Therapy In 64 Severe Traumatic Brain Injury Patients, Aged 18 to 60 Years Old Undergoing Emergency Craniotomies
Condition: Severe Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Emergencies; Wounds and Injuries
Study type: Interventional

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.
    

Detailed description: 
      This is a single centre, with equal randomisation, single blind, parallel group study
      conducted in Hospital Universiti Sains Malaysia. The physician allocated to the standard
      monitoring or PVI group were aware of the allocated arm, wherelse the next of kin were
      blinded to the allocated arm.

      This study took place in Hospital Universiti Sains Malaysia , Kubang Kerian , Kelantan from
      July 2019 Until October 2020. Patient who presented to emergency department HUSM diagnosed
      with severe traumatic brain injury based on a GCS ( Glasgow Coma Scale ≤ 8), Brain CT Scan
      finding (based on Marshall and Rotterdam scoring), and the SAPS (simplified acute physical
      injury) score and were planned for craniotomies were assessed for eligibility.

      Randomisation sequence was already created using the online randomisation application.
      (www.randomizer.org), with a 1:1 allocation by the primary investigator. Once a patient with
      severe traumatic brain injury has been posted for an emergency craniotomy, a white envelope
      was given to the anesthetic medical officer, If the patient fulfils the eligibility criteria,
      and the next of kin have consented for recruitment to this study, a second sealed white
      envelope will be given to the anesthetic medical officer in charge, which contains data
      collection sheets and protocols. The envelope given was sequentially numbered and sealed ,
      with the patients name, identity card, and date of enrolment written on it by the physician.
      These sealed white envelopes, with the PVI machine was kept in a locked cupboard in the
      Anesthesia department in Hospital Universiti Sains Malaysia, only accessible to the primary
      investigator.

      Doctors in charge will be given a separate protocol for PVI based and Standard monitoring
      based which acts a a guide for fluid management in patients in from induction of anesthesia (
      0 H) and 24 hours post induction in the Intensive Care Unit (ICU) (24 H). Data was then
      collected by the principle investigator at the end of 24 hours, or reevaluated earlier if any
      adverse reaction was reported by the doctor in charge.

      The sample size calculation was performed using Power and Sample Size Calculations System, .
      From the study by Tat in 2016, the standard deviation for amount of fluid used was 2637.45,
      with a mean difference of 1361.31. The α value is set at 0.05 and power of study at 80%. The
      sample size is calculated using t test. Adding a drop out rate of 10%, the number in each arm
      will be 34. All statistical analysis was performed using Statistical Package for the Social
      Science (SPSS) version 26. Results were presented as frequency (percentages) for descriptive
      data, mean ( standard deviation) for total fluids as well as mean (confidence interval) for
      laboratory parameters.

      A total of 64 patient were deemed eligible. The demographic data in between groups were
      analyzed using descriptive analysis chi square test. Independent t-test was used to analyze
      the total volume and different types of fluid used. The difference in lactate, pH, BE, Sodium
      and Chloride- and Creatinine between groups was analysed using the Independent t-test.
    

Intervention name(s): Plethymographic Variability Index; Standard Monitoring
Intervention type(s): Device; Device
Intervention description(s): 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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a single centre, with equal randomisation, single blind, parallel group study conducted in Hospital Universiti Sains Malaysia
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Plethysmographic variability index; standard monitoring; emergency craniotomies