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

NACompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

May 29, 2019

Primary Completion Date

October 30, 2020

Study Completion Date

October 30, 2020

Conditions
Severe Traumatic Brain Injury
Interventions
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"

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.

Trial Locations (1)

16150

Hospital Universiti Sains Malaysia, Kota Bharu

All Listed Sponsors
lead

Universiti Sains Malaysia

OTHER

NCT04664699 - 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 | Biotech Hunter | Biotech Hunter