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 (PVI)

December 6, 2020 updated by: Radha Ramanathan, Universiti Sains Malaysia

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kelantan
      • Kota Bahru, Kelantan, Malaysia, 16150
        • Hospital Universiti Sains Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are between 18-60 years old
  • ASA (American Society of Anaesthesiology)I and II
  • Diagnosed with Severe Traumatic Brain Injury (based on a GCS ( Glasgow Coma Scale ≤ 8) , intubated and consented for neurosurgeries

Exclusion Criteria:

  • Patients with serious cardiac arrhythmias
  • Patients with peripheral artery disease
  • Presence of renal or liver dysfunction
  • Presence of concurrent thoracic injury requiring higher ventilator settings with tidal volume > 10 ml/kg or PEEP > 10
  • Presence of extracranial major vascular injury ( upper limb, lower limb, intrathoracic or intrabdominal )
  • Patients with no valid consent from next of kin or caretaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Plethysmographic Variability Index group
32 patients who presented to emergency department HUSM diagnosed with severe traumatic brain injury who were randomly assigned to the PVI group
Device: Plethymographic Variability Index

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
Other: Standard monitoring group
32 patients who presented to emergency department HUSM diagnosed with severe traumatic brain injury who were randomly assigned to the standard monitoring group
Device: Standard Monitoring
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Types and amounts of fluids used
Time Frame: 0 and 24 hours
To compare the total amount and types of fluids (crystalloid, colloid and blood) used in both groups at induction of anaesthesia until at the end of 24 hours
0 and 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood lactate
Time Frame: 0 and 24 hours
To compare the mean difference in blood lactate levels in both at induction and at the end of 24 hours
0 and 24 hours
Sodium and chloride
Time Frame: 0 and 24 hours
To compare serum electrolytes (sodium and chloride) levels of both groups at induction and at the end of 24 hours
0 and 24 hours
pH and base excess
Time Frame: 0 and 24 hours
To compare pH and base excess of both groups at induction and at the end of 24 hours
0 and 24 hours
Creatinine
Time Frame: 0 and 24 hours
To compare serum creatinine of both groups at induction and at the end of 24 hours
0 and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2019

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

December 6, 2020

First Submitted That Met QC Criteria

December 6, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19010085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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