Clinical trial NCT03376347: Intraoperative Implementation of the Hypotension Probability Indicator
Official title: HYPE Trial. Intraoperative Implementation of the Hypotension Probability Indicator (HPI) Algorithm: a Pilot Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Hypotension
Keywords: intraoperative
hypotension
Hypotension Probability Index
HPI
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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:

* Aim for MAP other than 65 mmHg at discretion treating physician
* Significant hypotension before surgery defined as a MAP \<65
* Right- or left sided cardiac failure (e.g. LVEF\<35%)
* Known cardiac shunts (significant)
* Known aortic stenosis (severe)
* Severe cardiac arrhythmias including atrial fibrillation
* Requiring dialysis
* Liver surgery
* Vascular surgery with clamping of the aorta
* Perioperative Goal Directed Therapy (PGDT) protocol

Primary outcomes:
measure: TWA hypotension (measured with FlotracIQ)
timeFrame: intraoperative, starting 15 minutes after induction
Secondary outcomes:
measure: Incidence of hypotension (measured with FlotracIQ)
timeFrame: intraoperative, starting 15 minutes after induction
measure: Time spent in hypotension (measured with FlotracIQ)
timeFrame: intraoperative, starting 15 minutes after induction
measure: TWA hypertension (measured with FlotracIQ)
timeFrame: intraoperative, starting 15 minutes after induction
measure: Percentage of time in hypertension (measured with FlotracIQ)
timeFrame: intraoperative, starting 15 minutes after induction
measure: Incidence of hypertension (measured with FlotracIQ)
timeFrame: intraoperative, starting 15 minutes after induction
measure: Treatment choice (CRF, EPD)
timeFrame: intraoperative, starting 15 minutes after induction
measure: Treatment dose (CRF, EPD)
timeFrame: intraoperative, starting 15 minutes after induction
measure: Time to treatment (CRF)
timeFrame: intraoperative, starting 15 minutes after induction
measure: Diagnostic guidance protocol deviations (CRF)
timeFrame: intraoperative, starting 15 minutes after induction
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Amsterdam
Study officials:
affiliation: Academic Medical Center (AMC), Amsterdam
name: M.W. Hollmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
citation: Wijnberge M, Schenk J, Terwindt LE, Mulder MP, Hollmann MW, Vlaar AP, Veelo DP, Geerts BF. The use of a machine-learning algorithm that predicts hypotension during surgery in combination with personalized treatment guidance: study protocol for a randomized clinical trial. Trials. 2019 Oct 11;20(1):582. doi: 10.1186/s13063-019-3637-4.