Clinical Trials Directory

Trials / Completed

CompletedNCT03376347

Intraoperative Implementation of the Hypotension Probability Indicator

HYPE Trial. Intraoperative Implementation of the Hypotension Probability Indicator (HPI) Algorithm: a Pilot Randomized Controlled Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Reducing intraoperative hypotension using FlotracIQ with HPI software.

Detailed description

Intraoperative hypotension occurs often. Even short durations of hypotension are suggested to be associated with increased risk for renal insufficiency and myocardial ischemia. Currently treatment of these hypotensive episodes is not proactive. Edwards Lifesciences has developed an algorithm using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. Hypothesis: the use of this algorithm will alter treatment of hypotension and reduces the incidence of hypotension.

Conditions

Interventions

TypeNameDescription
DEVICEFlotracIQ with HPI algorithmFlotracIQ with hypotension probability indicator (HPI) algorithm connected to arterial line. The treating anesthetist is provided with guidance by means of a flowchart suggesting when to treat and what. Timing of treatment and choice of treatment is then left to the discretion of the attending physician.

Timeline

Start date
2017-11-08
Primary completion
2019-03-20
Completion
2019-03-20
First posted
2017-12-18
Last updated
2020-01-13

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT03376347. Inclusion in this directory is not an endorsement.