Severe Traumatic Brain InjuryPVINCT04664699
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
A study testing Plethymographic Variability Index and Standard Monitoring in people with Severe Traumatic Brain Injury, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Traumatic Brain Injury
- What is being tested?
- Plethymographic Variability Index and Standard Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteMalaysia
- Study dates
- 29 May 2019to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
About this study
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
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.
Read the 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.
- Conditions
- Severe Traumatic Brain Injury
- Being tested
- Plethymographic Variability Index, Standard Monitoring
- Keywords
- Plethysmographic variability index, standard monitoring, emergency craniotomies
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plethymographic Variability IndexDevice
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
Standard MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Standard Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 and 24 hours
Secondary outcomes (4)
Blood lactate
To compare the mean difference in blood lactate levels in both at induction and at the end of 24 hours
Measured: 0 and 24 hours
Sodium and chloride
To compare serum electrolytes (sodium and chloride) levels of both groups at induction and at the end of 24 hours
Measured: 0 and 24 hours
pH and base excess
To compare pH and base excess of both groups at induction and at the end of 24 hours
Measured: 0 and 24 hours
Creatinine
To compare serum creatinine of both groups at induction and at the end of 24 hours
Measured: 0 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start29 May 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single centre, with equal randomisation, single blind, parallel group study conducted in Hospital Universiti Sains Malaysia
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radha Ramanathan, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664699
- Sponsor's protocol ID
- 19010085
- Acronym
- PVI
- Status last verified
- Dec 2020
- First submitted
- 6 Dec 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27162857Pinsky MR, Payen D. Functional hemodynamic monitoring. Crit Care. 2005;9(6):566-72. doi: 10.1186/cc3927. Epub 2005 Nov 22.
PubMed 16356240Guerin 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.
PubMed 24012230Forget 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.
PubMed 20705785Yu 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.
PubMed 24557584Demirel 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.
PubMed 28762023Cesur 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.
PubMed 29948666Byon 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.
PubMed 23250892Fischer 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.
PubMed 32205547Liu 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.
PubMed 31068139Biais 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.
PubMed 21749695Fischer 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.
PubMed 25263772Chu 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.
PubMed 26242233Meng 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.
PubMed 30354725Carney 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.
PubMed 27654000
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04664699
- Acronym / sponsor ID
- PVI / 19010085
- Conditions
- Severe Traumatic Brain Injury
- Keywords
- Plethysmographic variability index, standard monitoring, emergency craniotomies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. (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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This is a single centre, with equal randomisation, single blind, parallel group study conducted in Hospital Universiti Sains Malaysia
| Arm | Type | Receives |
|---|---|---|
| Plethysmographic Variability Index group | Other | Device: Plethymographic Variability Index32 patients who presented to emergency department HUSM diagnosed with severe traumatic brain injury who were randomly assigned to the PVI group |
| Standard monitoring group | Other | Device: Standard Monitoring32 patients who presented to emergency department HUSM diagnosed with severe traumatic brain injury who were randomly assigned to the standard monitoring group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plethymographic Variability IndexAll 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 | Plethysmographic Variability Index group |
| Standard MonitoringAll 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. | Device | Standard monitoring group |
Primary outcome
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
4 secondary outcomes
Blood lactate
Time frame: 0 and 24 hours
Sodium and chloride
Time frame: 0 and 24 hours
pH and base excess
Time frame: 0 and 24 hours
Creatinine
Time frame: 0 and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Background: PubMed 27162857Alvis-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.
- Background: PubMed 16356240Pinsky MR, Payen D. Functional hemodynamic monitoring. Crit Care. 2005;9(6):566-72. doi: 10.1186/cc3927. Epub 2005 Nov 22.
- Background: PubMed 24012230Guerin 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.
- Background: PubMed 20705785Forget 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.
- Background: PubMed 24557584Yu 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.
- Background: PubMed 28762023Demirel 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.
- Background: PubMed 29948666Cesur 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.
- Background: PubMed 23250892Byon 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.
- Background: PubMed 32205547Fischer 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.
- Background: PubMed 31068139Liu 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.
- Background: PubMed 21749695Biais 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.
- Background: PubMed 25263772Fischer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plethymographic Variability Index and Standard Monitoring in people with Severe Traumatic Brain Injury, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Types and amounts of fluids used (time frame: 0 and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04664699, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.