Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000162819
Ethics application status
Approved
Date submitted
16/01/2020
Date registered
16/02/2021
Date last updated
16/02/2021
Date data sharing statement initially provided
16/02/2021
Date results information initially provided
16/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of HPI (Hypotension probability indicator) during major intracranial surgery, prospective single-center randomized study.
Scientific title
The influence of prospective hypotension diagnosis with HPI (Hypotension probability indicator) parameter on hypotension incidence during major intracranial surgery, randomized controlled trial.
Secondary ID [1] 297772 0
none
Universal Trial Number (UTN)
Trial acronym
HYPEX ( HYpotension Probability IndEX ) trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypotension 315863 0
Condition category
Condition code
Anaesthesiology 314141 314141 0 0
Other anaesthesiology
Cardiovascular 314997 314997 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use if HPI (Hypotension probability indicator).
To lower the incidence of perioperative hypotension in major intracranial surgery.
HPI provided via EV1000 device (Edwards lifescience, Irvine, CA).
EV1000 is an advanced monitor, which deeply analyses invasive arterial pressure curve from radial artery line. HPI is calculated parametr by artificial inteligence algorithm (machine learning based), which is supposed to predict hypotension events in the near future.
Use of HPI in intervention arm of study, preemptive treatment of hypotension through standard anaesthesia care. The measurement of HPI is continual, the intervention period lasts through whole surgery duration.
Intervention provided by skilled anesthesiologist in dept.of anaesthesia and critical care of university hospital.
Intervention code [1] 316555 0
Diagnosis / Prognosis
Intervention code [2] 317185 0
Treatment: Devices
Comparator / control treatment
Control group without the use of HPI parameter, standard care regarding anaesthesia for major intracranial surgery. Anaesthesia was induced by loading dose of propofol and sufentanil. Rocuronium was given to facilitate tracheal intubation. Maintenance phase of anaesthesia was held by continual infusion of remifentanil and propofol with controlled mechanical ventilation. Balanced crystalloid solution in the dose of 1ml/kg per hour was infused continually. In case of hypotensive event (defined as MAP below 65mmHg), bolus dose of crystalloid solution and/or vasopressor infusion were given to reestablish normotension. In intervention group, the extra trigger (in addition to MAP<65) for rising the blood pressure was HPI value above 85%
Control group
Active

Outcomes
Primary outcome [1] 322532 0
Incidence of hypotension through surgery.
The incidence of hypotension was retrospectively calculated from blood pressure medical record, which was continually gained (each 20 seconds) during the surgery.
Timepoint [1] 322532 0
The value of blood pressure was assessed in 20 second intervals throughout the whole surgery.
Primary outcome [2] 322533 0
Incidence of hypotension in maintenance phase of anaesthesia.
Incidence was assessed from digital medical record of blood pressure values throughout the anaesthesia, hypotension was defined as mean arterial pressure (MAP) below 65mmHg.
Timepoint [2] 322533 0
The value of blood pressure was assessed in 20 second intervals throughout the maintenance phase of anaesthesia. Maintenance phase of anaesthesia was defined as period starting 30minutes after induction of anaesthesia.
Secondary outcome [1] 378844 0
Morbidity in 30 days after surgery.
Outcome was assessed from hospital Medical Records System.
Timepoint [1] 378844 0
30 days after surgery
Secondary outcome [2] 378845 0
Full blood analysis (haematocrit, lactate, sodium, pH) was performed by Werfen GEM Premier 3500 device (Werfen Czech, Prague, Czech Republic) immediately after surgery and 6hours after - composite outcome.
Timepoint [2] 378845 0
Immediately after surgery and 6 hours after.
Secondary outcome [3] 378846 0
Amount of infused fluids through surgery.
Outcome was assessed from medical records system.
Timepoint [3] 378846 0
Outcome was assessed at the end of procedure.
Secondary outcome [4] 391919 0
Mortality.
Outcome was assessed from hospital Medical Records System.
Timepoint [4] 391919 0
Mortality within one year of the follow-up. (One year after surgery)

Eligibility
Key inclusion criteria
Major supratentorial brain surgery for tumor resection.
Expected length more than 1hour.
ASA physical status 1-3
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA physical status 4-5.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures with sealed envelope.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We plan to enroll 40 patients, 20 in each group. Ordinary statistics to compare groups will be held on - Student T-test, Chi square test, test for normality.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2018
Date of last participant enrolment
Anticipated
Actual
30/06/2020
Date of last data collection
Anticipated
Actual
30/06/2020
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 22233 0
Czech Republic
State/province [1] 22233 0

Funding & Sponsors
Funding source category [1] 302297 0
Hospital
Name [1] 302297 0
University Hospital Pilsen, Czech Republic
Country [1] 302297 0
Czech Republic
Primary sponsor type
Hospital
Name
University Hospital Pilsen, Czech Republic
Address
Alej Svobody 80,
Plzen, 30460
Czech Republic
Country
Czech Republic
Secondary sponsor category [1] 305019 0
None
Name [1] 305019 0
Address [1] 305019 0
Country [1] 305019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302972 0
Eticka komise FN Plzen
Ethics committee address [1] 302972 0
Eticka komise FN Plzen
Alej Svobody 80,
Plzen, 30460
Czech Republic
Ethics committee country [1] 302972 0
Czech Republic
Date submitted for ethics approval [1] 302972 0
21/02/2018
Approval date [1] 302972 0
28/02/2018
Ethics approval number [1] 302972 0

Summary
Brief summary
Major objective of this study is to assess HPI use to avoid hypotension through major intracranial surgery, Randomized prospective study is performed in a University hospital. Patients undergoing intracranial tumour resection with ASA status 1-3 are enrolled and randomly (1:1) assigned to interventional or control group. Anaesthesia is considered as standart care according to predefined protocol. HPI values are allowed only in intervention group. The value of more than 85% is considered as significant and in this case treatment to rise blood pressure is started. In control group HPI value is covered for anaesthesiologist. Number and duration of hypotensive events are used as primary indicator.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92026 0
Dr Jiri Pouska
Address 92026 0
Dpt. of Anesthesiology and Intensive Care Medicine, Faculty of Medicine in Plzen, Charles University, Plzen, Czech Republic
Alej Svobody 80
Fakultni nemocnice Plzen
30460 Plzen
Czech Republic
Country 92026 0
Czech Republic
Phone 92026 0
+420605215767
Fax 92026 0
Email 92026 0
[email protected]
Contact person for public queries
Name 92027 0
Dr Jiri Pouska
Address 92027 0
Dpt. of Anesthesiology and Intensive Care Medicine, Faculty of Medicine in Plzen, Charles University, Plzen, Czech Republic
Alej Svobody 80
Fakultni nemocnice Plzen
30460 Plzen
Czech Republic
Country 92027 0
Czech Republic
Phone 92027 0
+420605215767
Fax 92027 0
Email 92027 0
[email protected]
Contact person for scientific queries
Name 92028 0
Dr Jiri Pouska
Address 92028 0
Dpt. of Anesthesiology and Intensive Care Medicine, Faculty of Medicine in Plzen, Charles University, Plzen, Czech Republic
Alej Svobody 80
Fakultni nemocnice Plzen
30460 Plzen
Czech Republic
Country 92028 0
Czech Republic
Phone 92028 0
+420605215767
Fax 92028 0
Email 92028 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Authentic haemodynamic data will be not available because of technical reasons due to manufacturer storage and analysis.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA protocol based on hypotension probability indicator vs. standard care to prevent intraoperative hypotension during supratentorial brain surgery: a prospective randomized pilot trial.2023https://dx.doi.org/10.23736/S0375-9393.23.17197-5
N.B. These documents automatically identified may not have been verified by the study sponsor.