Status:
COMPLETED
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
Lead Sponsor:
Universiti Sains Malaysia
Conditions:
Severe Traumatic Brain Injury
Eligibility:
All Genders
18-60 years
Phase:
NA
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 l...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04664699
Start Date
May 29 2019
End Date
October 30 2020
Last Update
December 11 2020
Active Locations (1)
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1
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, Malaysia, 16150