SurgeryHPI-PACUNCT05335174
Hypotension Prediction Index in Postoperative Surgical Patients
An observational study of Surgery, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Device: HemoSphere monitor and Acumen IQ sensor.
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2022to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical patients with cardiovascular disease risk factors undergoing colorectal, hepatobiliary, or vascular surgery.
Who may be able to join
- 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
Who cannot join
- Planned admission to ICU;
- Refusal to participate;
- Previously enrolled in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mirana Rakotoarivony contact
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital, Anesthesia Department
Montreal, Quebec, H3S 1Y9
Yang Stephen, MD, MSc, (514) 340-8222, stephen.yang@mail.mcgill.ca
Rakotoarivony Mirana, mirana.rakotoarivony@affiliate.mcgill.ca
About this study
Official title: Hypotension Prediction Index in Postoperative Surgical Patients in the Post-anesthetic Recovery Room - a Feasibility Study
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Device: HemoSphere monitor and Acumen IQ sensor.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| HPI monitor | Not described Receives: Device: Device: HemoSphere monitor and Acumen IQ sensor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative hypotension
Describe the incidence of hypotension defined as MAP <65 intraoperatively.
Measured: in 12 months
Incidence of postoperative hypotension
Describe the incidence of postoperative hypotension defined as MAP <65 in the PACU
Measured: in 12 months
Hemodynamic changes with treatment of hypotension
Described the changes in cardiac index with each medical treatment of a hypotensive episode.
Measured: in 12 months
Secondary outcomes (2)
Sensitivity and Specificity of HPI
Sensitivity and Specificity of HPI compared to a hypotensive events in the postoperative setting
Measured: in 12 months
Cardiovascular outcomes
Number of patients with Mortality, MI, MINS, acute pulmonary edema, stroke, pulmonary embolism, deep vein thrombosis
Measured: in 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Yang, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Stephen Yang, MD, MSc, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335174
- Sponsor's protocol ID
- 2022-3143
- Acronym
- HPI-PACU
- Status last verified
- May 2025
- First submitted
- 11 Apr 2022
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypotension Prediction Index in Postoperative Surgical Patients in the Post-anesthetic Recovery Room - a Feasibility Study
- ClinicalTrials.gov ID
- NCT05335174
- Acronym / sponsor ID
- HPI-PACU / 2022-3143
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPI monitor | – | Device: Device: HemoSphere monitor and Acumen IQ sensor. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients with cardiovascular disease risk factors undergoing colorectal, hepatobiliary, or vascular surgery.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Planned admission to ICU;
- Refusal to participate;
- Previously enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | HPI monitor |
Primary outcome
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.
2 secondary outcomes
Sensitivity and Specificity of HPI
Time frame: in 12 months
Cardiovascular outcomes
Time frame: in 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirana Rakotoarivony contact
Stephen Yang, MD, MSc principal investigator
Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Yang, MD, MSc ((514) 340-8222, stephen.yang@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative hypotension (time frame: in 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.