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

NCT04664699 | Completed DMC

• 1 other identifier: 19010085
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Traumatic Brain Injury

Keywords

Plethysmographic variability index; standard monitoring; emergency craniotomies

Outcome Measures

Primary Outcomes (1)

• Types and amounts of fluids used

  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 Outcomes (4)

• Blood lactate

  0 and 24 hours

• Sodium and chloride

  0 and 24 hours

• pH and base excess

  0 and 24 hours

• Creatinine

  0 and 24 hours

Study Arms (2)

Plethysmographic Variability Index group

OTHER

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

Standard monitoring group

OTHER

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

Interventions

Plethymographic Variability Index DEVICE

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

Plethysmographic Variability Index group

Standard Monitoring DEVICE

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.

Standard monitoring group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

Related Publications (15)

• Alvis-Miranda HR, Castellar-Leones SM, Moscote-Salazar LR. Intravenous Fluid Therapy in Traumatic Brain Injury and Decompressive Craniectomy. Bull Emerg Trauma. 2014 Jan;2(1):3-14.

  PMID: 27162857 BACKGROUND

• Pinsky MR, Payen D. Functional hemodynamic monitoring. Crit Care. 2005;9(6):566-72. doi: 10.1186/cc3927. Epub 2005 Nov 22.

  PMID: 16356240 BACKGROUND

• Guerin L, Monnet X, Teboul JL. Monitoring volume and fluid responsiveness: from static to dynamic indicators. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):177-85. doi: 10.1016/j.bpa.2013.06.002.

  PMID: 24012230 BACKGROUND

• Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.

  PMID: 20705785 BACKGROUND

• Yu Y, Dong J, Xu Z, Shen H, Zheng J. Pleth variability index-directed fluid management in abdominal surgery under combined general and epidural anesthesia. J Clin Monit Comput. 2015 Feb;29(1):47-52. doi: 10.1007/s10877-014-9567-5. Epub 2014 Feb 21.

  PMID: 24557584 BACKGROUND

• Demirel I, Bolat E, Altun AY, Ozdemir M, Bestas A. Efficacy of Goal-Directed Fluid Therapy via Pleth Variability Index During Laparoscopic Roux-en-Y Gastric Bypass Surgery in Morbidly Obese Patients. Obes Surg. 2018 Feb;28(2):358-363. doi: 10.1007/s11695-017-2840-1.

  PMID: 28762023 BACKGROUND

• Cesur S, Cardakozu T, Kus A, Turkyilmaz N, Yavuz O. Comparison of conventional fluid management with PVI-based goal-directed fluid management in elective colorectal surgery. J Clin Monit Comput. 2019 Apr;33(2):249-257. doi: 10.1007/s10877-018-0163-y. Epub 2018 Jun 14.

  PMID: 29948666 BACKGROUND

• Byon HJ, Lim CW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness in mechanically ventilated children undergoing neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91. doi: 10.1093/bja/aes467. Epub 2012 Dec 18.

  PMID: 23250892 BACKGROUND

• Fischer MO, Lemoine S, Tavernier B, Bouchakour CE, Colas V, Houard M, Greub W, Daccache G, Hulet C, Compere V, Taing D, Lorne E, Parienti JJ, Hanouz JL; Optimization using the Pleth Variability Index (OPVI) Trial Group. Individualized Fluid Management Using the Pleth Variability Index: A Randomized Clinical Trial. Anesthesiology. 2020 Jul;133(1):31-40. doi: 10.1097/ALN.0000000000003260.

  PMID: 32205547 BACKGROUND

• Liu T, Xu C, Wang M, Niu Z, Qi D. Reliability of pleth variability index in predicting preload responsiveness of mechanically ventilated patients under various conditions: a systematic review and meta-analysis. BMC Anesthesiol. 2019 May 8;19(1):67. doi: 10.1186/s12871-019-0744-4.

  PMID: 31068139 BACKGROUND

• Biais M, Cottenceau V, Petit L, Masson F, Cochard JF, Sztark F. Impact of norepinephrine on the relationship between pleth variability index and pulse pressure variations in ICU adult patients. Crit Care. 2011 Jul 12;15(4):R168. doi: 10.1186/cc10310.

  PMID: 21749695 BACKGROUND

• Fischer MO, Pellissier A, Saplacan V, Gerard JL, Hanouz JL, Fellahi JL. Cephalic versus digital plethysmographic variability index measurement: a comparative pilot study in cardiac surgery patients. J Cardiothorac Vasc Anesth. 2014 Dec;28(6):1510-5. doi: 10.1053/j.jvca.2014.05.003. Epub 2014 Sep 26.

  PMID: 25263772 BACKGROUND

• Chu H, Wang Y, Sun Y, Wang G. Accuracy of pleth variability index to predict fluid responsiveness in mechanically ventilated patients: a systematic review and meta-analysis. J Clin Monit Comput. 2016 Jun;30(3):265-74. doi: 10.1007/s10877-015-9742-3. Epub 2015 Aug 5.

  PMID: 26242233 BACKGROUND

• Meng L, Yu W, Wang T, Zhang L, Heerdt PM, Gelb AW. Blood Pressure Targets in Perioperative Care. Hypertension. 2018 Oct;72(4):806-817. doi: 10.1161/HYPERTENSIONAHA.118.11688. No abstract available.

  PMID: 30354725 BACKGROUND

• Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.

  PMID: 27654000 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: next of kin were blinded to the allocated arm
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: This is a single centre, with equal randomisation, single blind, parallel group study conducted in Hospital Universiti Sains Malaysia

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 11, 2020
• Study Start: May 29, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)