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NCT Number: NCT05335174

Hypotension Prediction Index in Postoperative Surgical Patients

PACU-HPI study evaluates the use of a hemodynamic monitor in the post-anesthetic recovery room on patients undergoing colorectal, hepatobiliary, and vascular surgery, to determine the feasibility of recruiting this surgical population.

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Key information

Conditions

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jewish General Hospital, Anesthesia Department

Montreal, Quebec, H3S 1Y9, Canada

Location status: Recruiting

Location contact

Rakotoarivony Mirana

CONTACT

[email protected]

Yang Stephen, MD, MSc

CONTACT

[email protected]

(514) 340-8222

Yang Stephen, MD, MSc

PRINCIPAL_INVESTIGATOR

About this study

Postoperative vascular complications, including myocardial infarction (MI), myocardial injury after noncardiac surgery (MINS), stroke, and death occur in up to 18% of surgical patients.1 Hypotension is a frequent occurrence in the postoperative period and can increase the risk of postoperative vascular complications.2 Therefore, accurate prediction of postoperative hypotension can identify patients at risk for postoperative vascular complications who would benefit from early intervention. The investigators propose a feasibility study to determine the accuracy of the hypotension prediction index (HPI) parameter of the HemoSphere monitor and Acumen IQ sensor (Edwards Lifesciences, Irvine, CA) to predict postoperative hypotension in surgical patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient ≥45 years old
  • Will undergo open colorectal, hepatobiliary, or vascular surgery;
  • Is expected to have an arterial cannula inserted intraoperatively;
  • Has an anticipated stay in PACU for at least 2 hours;
  • Able to provide written informed consent

Exclusion criteria

  • Planned admission to ICU;
  • Refusal to participate;
  • Previously enrolled in the study

Treatment and study plan

Device: HemoSphere monitor and Acumen IQ sensor.

Device

Patients will be placed on this monitor for the duration of study in the PACU. Followed by 30-day phone call to record cardiovascular complications.

Primary outcomes

  1. Incidence of intraoperative hypotension

    Time frame: in 12 months

    Describe the incidence of hypotension defined as MAP <65 intraoperatively.

  2. Incidence of postoperative hypotension

    Time frame: in 12 months

    Describe the incidence of postoperative hypotension defined as MAP <65 in the PACU

  3. Hemodynamic changes with treatment of hypotension

    Time frame: in 12 months

    Described the changes in cardiac index with each medical treatment of a hypotensive episode.

Secondary outcomes

  1. Sensitivity and Specificity of HPI

    Time frame: in 12 months

    Sensitivity and Specificity of HPI compared to a hypotensive events in the postoperative setting

  2. Cardiovascular outcomes

    Time frame: in 12 months

    Number of patients with Mortality, MI, MINS, acute pulmonary edema, stroke, pulmonary embolism, deep vein thrombosis

Study contacts

Contact information is provided by the study sponsor or research team.

Mirana Rakotoarivony

CONTACT

[email protected]

Stephen Yang, MD, MSc

CONTACT

[email protected]

(514) 340-8222

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Registry information

Official study title

Hypotension Prediction Index in Postoperative Surgical Patients in the Post-anesthetic Recovery Room - a Feasibility Study

Acronym: HPI-PACU

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2022
Registry last updated
May 18, 2025

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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