Skip to main content
OpenTrials
Completed

NCT Number: NCT03376347

Intraoperative Implementation of the Hypotension Probability Indicator

Reducing intraoperative hypotension using FlotracIQ with HPI software.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intraoperative Hypotension Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center Amsterdam

Amsterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FlotracIQ with HPI algorithm

Device

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 outcomes

  1. TWA hypotension (measured with FlotracIQ)

    Time frame: intraoperative, starting 15 minutes after induction

    Time weighted average spent in hypotension, defined as MAP <65mmHg for ≥1min

Secondary outcomes

  1. Incidence of hypotension (measured with FlotracIQ)

    Time frame: intraoperative, starting 15 minutes after induction

    Incidence of hypotension, defined as MAP <65mmHg for ≥1min

  2. Time spent in hypotension (measured with FlotracIQ)

    Time frame: intraoperative, starting 15 minutes after induction

    Time spent in hypotension, in minutes, defined as MAP <65mmHg for ≥1min

  3. TWA hypertension (measured with FlotracIQ)

    Time frame: intraoperative, starting 15 minutes after induction

    Time weighted average spent in hypertension, defined as MAP >100 mmHg for ≥1min

  4. Percentage of time in hypertension (measured with FlotracIQ)

    Time frame: intraoperative, starting 15 minutes after induction

    Percentage of time in hypertension, defined as MAP >100 mmHg for ≥1min

  5. Incidence of hypertension (measured with FlotracIQ)

    Time frame: intraoperative, starting 15 minutes after induction

    Incidence of hypertension, defined as MAP >100 mmHg for ≥1min.

  6. Treatment choice (CRF, EPD)

    Time frame: intraoperative, starting 15 minutes after induction

    Medication used to prevent/treat hypotension. A study member is present at the OR to make notes

  7. Treatment dose (CRF, EPD)

    Time frame: intraoperative, starting 15 minutes after induction

    Dose of medication used to prevent/treat hypotension. A study member is present at the OR to make notes

  8. Time to treatment (CRF)

    Time frame: intraoperative, starting 15 minutes after induction

    time to treatment of hypotension, defined as MAP <65mmHg for ≥1min. A study member is present at the OR to make notes

  9. Diagnostic guidance protocol deviations (CRF)

    Time frame: intraoperative, starting 15 minutes after induction

    Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Acronym: HYPE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 18, 2017
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.