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Completed

NCT Number: NCT03805217

Hypotension Prediction Index Study (HPI Study)

A prospective, single-arm, open-label, multicenter post-approval study to determine whether the use of the Acumen HPI Software to guide intraoperative hemodynamic management in non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of Mean Arterial Pressure (MAP)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Health Care, Stanford, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent;
  • Age ≥ 18 years;
  • ASA Physical Status 3 or 4;
  • Moderate- or high-risk non-cardiac surgery (for example, orthopedic, spine, urology, and general surgery);
  • Planned pressure monitoring with an arterial line;
  • General anesthesia;
  • Surgery duration expected to last ≥ 3 hours from induction;
  • Planned overnight hospitalization.

Exclusion criteria

  • Participating in another (interventional) study;
  • Contraindication to the invasive blood pressure monitoring;
  • Patient who is confirmed to be pregnant and/or nursing mothers;
  • Emergency surgery;
  • Known clinically important intra-cardiac shunts;
  • Patient in whom an intraoperative MAP target will be < 65 mmHg;
  • Known aortic stenosis with valve area ≤ 1.5 cm2;
  • Known moderate to severe aortic regurgitation;
  • Known moderate to severe mitral regurgitation;
  • Known moderate to severe mitral stenosis;
  • Patient or surgical procedure type known as an SVV limitation (5) (e.g. tidal volume <8mL/kg of theoretical ideal weight, spontaneous ventilation, persistent cardiac arrhythmia, known atrial fibrillation, open chest surgery, Heart Rate/Respiratory Rate (HR/RR) ratio <3.6);
  • Current persistent atrial fibrillation;
  • Known acute congestive heart failure;
  • Craniotomy;
  • Surgery duration expected to last < 3 hours;
  • Burn surgeries;
  • Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
  • Patient transfer from ICU requiring multiple vasoactive agents and known diagnosis of ongoing active sepsis.

Treatment and study plan

EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software

Device

EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software

Primary outcomes

  1. Reduction of Intraoperative Hypotension

    Time frame: Duration of Surgery

    Duration (t [min]) reduction of intraoperative hypotension (defined as MAP < 65 mmHg for at least 1 minute) as compared with a historic retrospective control group

Secondary outcomes

  1. Intraoperative Hypotension in Each Subject

    Time frame: Duration of Surgery

    The determination of total area under the curve (time and MAP) for Intraoperative Hypotension in each subject. This endpoint is correlated with the duration and a descriptive analysis of this endpoint will be presented with the mean, standard deviation, median, minimum and maximum.

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Prospective, Single-Arm, Open-Label, Multicenter Study of Hypotension Prevention and Treatment in Patients Receiving Arterial Pressure Monitoring with Acumen™ Hypotension Prediction Index Feature Software

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 15, 2019
Registry last updated
Oct 18, 2024

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.

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