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Clinical Trials/NCT05335174
NCT05335174
Recruiting
Not Applicable

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

Sir Mortimer B. Davis - Jewish General Hospital1 site in 1 country30 target enrollmentApril 1, 2022
ConditionsSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Enrollment
30
Locations
1
Primary Endpoint
Incidence of intraoperative hypotension
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
March 1, 2027
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Stephen Yang

Assistant Professor, Department of Anesthesia, Principal Investigator

Sir Mortimer B. Davis - Jewish General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence of intraoperative hypotension

Time Frame: in 12 months

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

Incidence of postoperative hypotension

Time Frame: in 12 months

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

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

  • Sensitivity and Specificity of HPI(in 12 months)
  • Cardiovascular outcomes(in 12 months)

Study Sites (1)

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