Hypotension Prediction Index in Postoperative Surgical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Device: HemoSphere monitor and Acumen IQ sensor..
- Who it may be relevant to
- Registry conditions: Surgery. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hypotension Prediction Index in Postoperative Surgical Patients in the Post-anesthetic Recovery Room - a Feasibility Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Incidence of intraoperative hypotension [Time frame: in 12 months]
- Incidence of postoperative hypotension [Time frame: in 12 months]
- Hemodynamic changes with treatment of hypotension [Time frame: in 12 months]
Secondary outcome measures (2)
- Sensitivity and Specificity of HPI [Time frame: in 12 months]
- Cardiovascular outcomes [Time frame: in 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Jewish General Hospital, Anesthesia Department — Montreal
Identifiers
NCT: NCT05335174 · 2022-3143