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Clinical trial

Use of the Hypotension Prediction Index Algorithm (HPI) for the Prevention of Intraoperative Hypotension (IOH) in Adult Patients Undergoing Spinal Surgery: Study Protocol for a Randomized Clinical Trial

ID
Name
HPIFPIOH
Description
The aim of this study is to investigate the hypothesis that the use of the Hypotension Prediction Index algorithm (HPI) can reduce intraoperative hypotension (IOH) in adult patients undergoing spinal surgery in the prone position under general anesthesia, as well as to explore its effect on in-hospital postoperative morbidity and mortality.
Trial arms
Trial start
2022-06-06
Estimated PCD
2023-12-01
Trial end
2024-04-01
Status
Recruiting
Treatment
HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpi
The HPI algorithm will be used in order to prevent hypotensive episodes. When the HPI is greater than 85%, the anesthesiologist will have to intervene within the next 2 minutes taking the hemodynamic parameters available into consideration, as well as the treatment protocol that has been designed according to current literature
Arms:
Intervention group:
Other names:
noradrenaline, phenylephrine
Vasoactive Agent
Hypotensive episodes will be treated with vasoactive agents and fluids. The HPI algorithm recordings will be blinded and will not be available to the anesthesiologist for the duration of the operation.
Arms:
Control group:, Intervention group:
Other names:
noradrenaline, phenylephrine
Size
40
Primary endpoint
Time-weighted average (TWA) in hypotension
Up to 15 minutes after the end of operation
Eligibility criteria
Inclusion Criteria: * Adult patients undergoing scheduled spine surgery performed in prone position under general anaesthesia Exclusion Criteria: * Heart failure with reduced ejection fraction (LVEF\<35%) * Severe aortic and/or mitral regurgitation * Persistent atrial fibrillation or other significant cardiac arrhythmias * Significant preoperative hypotension * End-stage renal disease on dialysis/RRT
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, Randomized, Double-Blinded clinical trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Not aware of the study group', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-07-20

1 organization

1 product

1 indication

Organization
Attikon Hospital
Product
Vasoactive Agent
Indication
Hypotension