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
| Type | Name | Description |
|---|---|---|
| DEVICE | FlotracIQ with HPI algorithm | FlotracIQ 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.