None listed
Conditions
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.
Interventions
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 s
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.
Sponsors
University Hospital Pilsen, Czech Republic
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Major supratentorial brain surgery for tumor resection. Expected length more than 1hour. ASA physical status 1-3
Exclusion criteria
ASA physical status 4-5.
Outcome results
None listed