Hypotension Prediction Index in Postoperative Surgical Patients

Surgery Clinical Trial

— HPI-PACU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335174
• Other study ID #: 2022-3143
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2022
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: Stephen Yang, MD, MSc
• Phone: (514) 340-8222
• Email: stephen.yang[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Canada	Jewish General Hospital, Anesthesia Department	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intraoperative hypotension	Describe the incidence of hypotension defined as MAP <65 intraoperatively.	in 12 months
Primary	Incidence of postoperative hypotension	Describe the incidence of postoperative hypotension defined as MAP <65 in the PACU	in 12 months
Primary	Hemodynamic changes with treatment of hypotension	Described the changes in cardiac index with each medical treatment of a hypotensive episode.	in 12 months
Secondary	Sensitivity and Specificity of HPI	Sensitivity and Specificity of HPI compared to a hypotensive events in the postoperative setting	in 12 months
Secondary	Cardiovascular outcomes	Number of patients with Mortality, MI, MINS, acute pulmonary edema, stroke, pulmonary embolism, deep vein thrombosis	in 12 months