Recruiting

Observational Study

Sponsor:

Sir Mortimer B. Davis - Jewish General Hospital

Code:

NCT05335174

Conditions

Surgery

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Device: HemoSphere monitor and Acumen IQ sensor.

Study Details

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

Study ID

NCT05335174

Start date

Apr 1, 2022

Status verified date

May, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not 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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

HPI monitor

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Stephen Yang, MD, MSc

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

Mirana Rakotoarivony

mirana.rakotoarivony@affiliate.mcgill.ca

Locations

Jewish General Hospital, Anesthesia Department

Recruiting

Montréal, Quebec, Canada, H3S 1Y9

Contacts

Yang Stephen, MD, MSc

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

Rakotoarivony Mirana

mirana.rakotoarivony@affiliate.mcgill.ca

Principal Investigator:

Yang Stephen, MD, MSc

More Information

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Last update posted

May 18, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sir Mortimer B. Davis - Jewish General Hospital on 2025-05-18.