Hypotension Prediction Index in Postoperative Surgical Patients

NCT05335174 | Recruiting

• 1 other identifier: 2022-3143
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Sensitivity and Specificity of HPI

  in 12 months

• Cardiovascular outcomes

  in 12 months

Study Arms (1)

HPI monitor

Device: Device: HemoSphere monitor and Acumen IQ sensor.

Interventions

Device: HemoSphere monitor and Acumen IQ sensor. DEVICE

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.

HPI monitor

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Planned admission to ICU;
• Refusal to participate;
• Previously enrolled in the study

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital, Anesthesia Department

Montreal, Quebec, H3S 1Y9, Canada

RECRUITING

Study Officials

• Stephen Yang, MD, MSc

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Yang, MD, MSc

CONTACT

(514) 340-8222; stephen.yang@mail.mcgill.ca

Mirana Rakotoarivony

CONTACT

mirana.rakotoarivony@affiliate.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesia, Principal Investigator

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 19, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

CA (1)