Hypotension Prediction Index in Postoperative Surgical Patients (HPI-PACU)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery
• Intervention / Treatment: Device: Device: HemoSphere monitor and Acumen IQ sensor.

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Mirana Rakotoarivony; Email: mirana.rakotoarivony@affiliate.mcgill.ca
• Study Contact Backup: Name: Stephen Yang, MD, MSc; Phone Number: (514) 340-8222; Email: stephen.yang@mail.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3S 1Y9
      • Recruiting
      • Jewish General Hospital, Anesthesia Department
      • Contact: Yang Stephen, MD, MSc; Phone Number: (514) 340-8222; Email: stephen.yang@mail.mcgill.ca
      • Contact: Rakotoarivony Mirana; Email: mirana.rakotoarivony@affiliate.mcgill.ca
      • Principal Investigator: Yang Stephen, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Surgical patients with cardiovascular disease risk factors undergoing colorectal, hepatobiliary, or vascular surgery.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Planned admission to ICU;
2. Refusal to participate;
3. Previously enrolled in the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HPI monitor	Device: Device: HemoSphere monitor and Acumen IQ sensor.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hypotension	Describe the incidence of hypotension defined as MAP <65 intraoperatively.	in 12 months
Incidence of postoperative hypotension	Describe the incidence of postoperative hypotension defined as MAP <65 in the PACU	in 12 months
Hemodynamic changes with treatment of hypotension	Described the changes in cardiac index with each medical treatment of a hypotensive episode.	in 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of HPI	Sensitivity and Specificity of HPI compared to a hypotensive events in the postoperative setting	in 12 months
Cardiovascular outcomes	Number of patients with Mortality, MI, MINS, acute pulmonary edema, stroke, pulmonary embolism, deep vein thrombosis	in 12 months

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Investigators: Principal Investigator: Stephen Yang, MD, MSc, Jewish General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: 2022-3143

Drug and device information, study documents

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