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Intraoperative implementation of the hypotension probability indicator (HPI) algorithm a pilot randomized controlled clinical trial

Intraoperative implementation of the hypotension probability indicator (HPI) algorithm a pilot randomized controlled clinical trial - HYPE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46783
Enrollment
100
Registered
2018-03-16
Start date
2017-11-07
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamiek. Intraoperatief hypotension low blood pressure

Interventions

We look at the effect of introduction of a protocol (based on FloTracIQ) with blood pressure targets and predictive analytics (HPI) to reduce the time weighted average (TWA) spent in hypotension dur
Anesthesiology
Hypotension
Intraoperative monitoring
Machine learning

Sponsors

Academisch Medisch Centrum Amsterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Aged 18 years or older * Planned for elective non-cardiac non-day surgery with an expected duration of more than 2 hours * Planned to receive general anaesthesia * Planned to receive an arterial line during surgery * Aim for MAP of 65 mmHg during surgery * Being able to give written informed consent prior to surgery

Exclusion criteria

Exclusion criteria: * Aim for MAP other than 65 mmHg at discretion treating physician * Significant hypotension before surgery defined as a MAP

Design outcomes

Primary

MeasureTime frame
Phase A: Prospective data collection Main study parameters/endpoints * Time weighted average spent in hypotension (defined as MAP100 mmHg) during surgery? * Incidence of hypertension (defined as MAP >100 mmHg) during surgery? * TWA spent in hypertension (defined as MAP>100 mmHg) during surgery? * Hemodynamic parameters, measured beat tot beat (CO, SV, SVV, SVR, elastance, dP/dT) Phase B: RCT Main study parameters/endpoints We compare a group with access to HPI and access to FlotracIQ parameters (CO, SV, SVR, SVV, dynamic elastance, dP/dT, see appendix II) to a group treated according to institutional standard care. * Time weighted average spent in hypotension (defined as MAP100 mmHg) during and after surgery? * Incidence of hypertension (defined as MAP >100 mmHg) during and after surgery? * TWA spent in hypertension (defined as MAP>100 mmHg) during and after surgery?

Secondary

MeasureTime frame
See primary study parameters

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)