Intraoperative Implementation of the Hypotension Probability Indicator (HYPE)

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

Reducing intraoperative hypotension using FlotracIQ with HPI software.

Study Overview

• Status: Completed
• Conditions: Intraoperative Hypotension
• Intervention / Treatment: Device: FlotracIQ with HPI algorithm

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Academic Medical Center Amsterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Conventional arm; Institutional Standard of Care with intention to keep MAP> 65 mmHg. The FlotracIQ will be connected, but fully covered.
ACTIVE_COMPARATOR: Treatment arm; FlotracIQ with HPI algorithm.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TWA hypotension (measured with FlotracIQ)	Time weighted average spent in hypotension, defined as MAP <65mmHg for ≥1min	intraoperative, starting 15 minutes after induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension (measured with FlotracIQ)	Incidence of hypotension, defined as MAP <65mmHg for ≥1min	intraoperative, starting 15 minutes after induction
Time spent in hypotension (measured with FlotracIQ)	Time spent in hypotension, in minutes, defined as MAP <65mmHg for ≥1min	intraoperative, starting 15 minutes after induction
TWA hypertension (measured with FlotracIQ)	Time weighted average spent in hypertension, defined as MAP >100 mmHg for ≥1min	intraoperative, starting 15 minutes after induction
Percentage of time in hypertension (measured with FlotracIQ)	Percentage of time in hypertension, defined as MAP >100 mmHg for ≥1min	intraoperative, starting 15 minutes after induction
Incidence of hypertension (measured with FlotracIQ)	Incidence of hypertension, defined as MAP >100 mmHg for ≥1min.	intraoperative, starting 15 minutes after induction
Treatment choice (CRF, EPD)	Medication used to prevent/treat hypotension. A study member is present at the OR to make notes	intraoperative, starting 15 minutes after induction
Treatment dose (CRF, EPD)	Dose of medication used to prevent/treat hypotension. A study member is present at the OR to make notes	intraoperative, starting 15 minutes after induction
Time to treatment (CRF)	time to treatment of hypotension, defined as MAP <65mmHg for ≥1min. A study member is present at the OR to make notes	intraoperative, starting 15 minutes after induction
Diagnostic guidance protocol deviations (CRF)	Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.	intraoperative, starting 15 minutes after induction

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: M.W. Hollmann, MD, PhD, Academic Medical Center (AMC), Amsterdam

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 8, 2017
• Primary Completion (ACTUAL): March 20, 2019
• Study Completion (ACTUAL): March 20, 2019

Study Registration Dates

• First Submitted: December 3, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (ACTUAL): December 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: hypotension; intraoperative; HPI; Hypotension Probability Index
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: NL 6211501817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No