Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04664699
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2020-12-06
Brief Title:
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
Sponsor:
Universiti Sains Malaysia
Organization:
Universiti Sains Malaysia
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PVI
Brief 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 wwwrandomizerorg with a 11 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 263745 with a mean difference of 136131 The α value is set at 005 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
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 wwwrandomizerorg with a 11 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 263745 with a mean difference of 136131 The α value is set at 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None