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Intraoperative Implementation of the Hypotension Probability Indicator (HYPE)

Primary Purpose

Intraoperative Hypotension

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
FlotracIQ with HPI algorithm
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Hypotension focused on measuring intraoperative, hypotension, Hypotension Probability Index, HPI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Academic Medical Center Amsterdam

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Conventional arm

Treatment arm

Arm Description

Institutional Standard of Care with intention to keep MAP> 65 mmHg. The FlotracIQ will be connected, but fully covered.

FlotracIQ with HPI algorithm.

Outcomes

Primary Outcome Measures

TWA hypotension (measured with FlotracIQ)
Time weighted average spent in hypotension, defined as MAP <65mmHg for ≥1min

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2017
Last Updated
January 9, 2020
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT03376347
Brief Title
Intraoperative Implementation of the Hypotension Probability Indicator
Acronym
HYPE
Official Title
HYPE Trial. Intraoperative Implementation of the Hypotension Probability Indicator (HPI) Algorithm: a Pilot Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
March 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Hypotension
Keywords
intraoperative, hypotension, Hypotension Probability Index, HPI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional arm
Arm Type
No Intervention
Arm Description
Institutional Standard of Care with intention to keep MAP> 65 mmHg. The FlotracIQ will be connected, but fully covered.
Arm Title
Treatment arm
Arm Type
Active Comparator
Arm Description
FlotracIQ with HPI algorithm.
Intervention Type
Device
Intervention Name(s)
FlotracIQ with HPI algorithm
Intervention Description
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.
Primary Outcome Measure Information:
Title
TWA hypotension (measured with FlotracIQ)
Description
Time weighted average spent in hypotension, defined as MAP <65mmHg for ≥1min
Time Frame
intraoperative, starting 15 minutes after induction
Secondary Outcome Measure Information:
Title
Incidence of hypotension (measured with FlotracIQ)
Description
Incidence of hypotension, defined as MAP <65mmHg for ≥1min
Time Frame
intraoperative, starting 15 minutes after induction
Title
Time spent in hypotension (measured with FlotracIQ)
Description
Time spent in hypotension, in minutes, defined as MAP <65mmHg for ≥1min
Time Frame
intraoperative, starting 15 minutes after induction
Title
TWA hypertension (measured with FlotracIQ)
Description
Time weighted average spent in hypertension, defined as MAP >100 mmHg for ≥1min
Time Frame
intraoperative, starting 15 minutes after induction
Title
Percentage of time in hypertension (measured with FlotracIQ)
Description
Percentage of time in hypertension, defined as MAP >100 mmHg for ≥1min
Time Frame
intraoperative, starting 15 minutes after induction
Title
Incidence of hypertension (measured with FlotracIQ)
Description
Incidence of hypertension, defined as MAP >100 mmHg for ≥1min.
Time Frame
intraoperative, starting 15 minutes after induction
Title
Treatment choice (CRF, EPD)
Description
Medication used to prevent/treat hypotension. A study member is present at the OR to make notes
Time Frame
intraoperative, starting 15 minutes after induction
Title
Treatment dose (CRF, EPD)
Description
Dose of medication used to prevent/treat hypotension. A study member is present at the OR to make notes
Time Frame
intraoperative, starting 15 minutes after induction
Title
Time to treatment (CRF)
Description
time to treatment of hypotension, defined as MAP <65mmHg for ≥1min. A study member is present at the OR to make notes
Time Frame
intraoperative, starting 15 minutes after induction
Title
Diagnostic guidance protocol deviations (CRF)
Description
Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.
Time Frame
intraoperative, starting 15 minutes after induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M.W. Hollmann, MD, PhD
Organizational Affiliation
Academic Medical Center (AMC), Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center Amsterdam
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32065827
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.
Results Reference
derived
PubMed Identifier
31601239
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.
Results Reference
derived

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Intraoperative Implementation of the Hypotension Probability Indicator

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