Hypotension Prediction Index in Postoperative Surgical Patients

Recruiting

• Conditions: Surgery

• Registration Number: NCT05335174
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jewish General Hospital, Anesthesia Department; 🇨🇦 Montréal, Quebec, Canada