Health TrialsbyHealthPanel

Hypotension Prediction Index in Postoperative Surgical Patients

ConditionSurgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorSir Mortimer B. Davis - Jewish General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Planned admission to ICU;

Refusal to participate;

Previously enrolled in the study

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: HPI monitor1 intervention

Trial outcomes

Primary outcomes

1

Incidence of intraoperative hypotension

Describe the incidence of hypotension defined as MAP \<65 intraoperatively.

Time frame
in 12 months
2

Incidence of postoperative hypotension

Describe the incidence of postoperative hypotension defined as MAP \<65 in the PACU

Time frame
in 12 months
3

Hemodynamic changes with treatment of hypotension

Described the changes in cardiac index with each medical treatment of a hypotensive episode.

Time frame
in 12 months

Secondary outcomes

1

Sensitivity and Specificity of HPI

Sensitivity and Specificity of HPI compared to a hypotensive events in the postoperative setting

Time frame
in 12 months
2

Cardiovascular outcomes

Number of patients with Mortality, MI, MINS, acute pulmonary edema, stroke, pulmonary embolism, deep vein thrombosis

Time frame
in 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sir Mortimer B. Davis - Jewish General Hospital

Lead sponsor

Source ClinicalTrials.gov
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