Hypotension Prediction Index in Postoperative Surgical Patients

NCT ID: NCT05335174

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2027-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HPI monitor

Device: HemoSphere monitor and Acumen IQ sensor.

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stephen Yang

Assistant Professor, Department of Anesthesia, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephen Yang, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jewish General Hospital, Anesthesia Department

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stephen Yang, MD, MSc

Role: CONTACT

(514) 340-8222

Mirana Rakotoarivony

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yang Stephen, MD, MSc

Role: primary

(514) 340-8222

Rakotoarivony Mirana

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-3143

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.