Hypotension Prediction Index Based Perioperative Protocolized Hemodynamic Management in Geriatric Orthopedic Surgery

National Taiwan University

Status: Unknown

Conditions: Orthopedic Disorder; Hemodynamic Instability

Treatments: Other: ordinary goal-directed hemodynamic therapy; Other: hypotension prediction index(HPI)

Study type: Interventional

Funder types: Other

Identifiers

NCT05274412

202112163RIND

Details and patient eligibility

About

Blood pressure optimization has been considered as a crucial factor to avoid perioperative vital organ hypoperfusion, and perioperative hypotension has been addressed as a risk factor for complications and adverse clinical outcomes.

Hypotension prediction index (HPI) is an novel machine-learning derived parameters, and was developed to predict the risk of future hypotension.Series of clinical studies have verified its clinical efficacy in avoiding perioperative hypotension.

Major orthopedic surgeries, such as spine surgery, joint surgery, long bone fracture surgery, are quite common in elder people, who are vulnerable to perioperative adverse outcomes.Thus the investigator design this study to testify the clinical efficacy of implementing HPI in perioperative goal-directed hemodynamic therapy in elder patients receiving major orthopedic surgery.

Enrollment: 280 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults elder or equal to 60 years old receiving scheduled orthopedic surgery

Exclusion criteria

• Patients with a history of arrhythmia, congestive heart failure, preoperative neurocognitive disorder, cerebrovascular event, chronic obstructive pulmonary disease, chronic kidney disease, ongoing infectious disease, will be excluded.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 2 patient groups

Control group

Active Comparator group

Description:

Participants in this group will receive protocolized hemodynamic management based on advanced hemodynamic monitoring and dynamic parameters.Keep pulse pressure variation \>12%; keep cardiac index \>2L/min/cm\^2; keep mean arterial pressure \> 65mmHg.

Treatment:

Other: ordinary goal-directed hemodynamic therapy

HPI group

Experimental group

Description:

Participants in this group will receive protocolized hemodynamic management based on advanced hemodynamic monitoring, hypotension prediction index (HPI), and dynamic parameters.Keep HPI \<85; pulse pressure variation \>12%; keep cardiac index \>2L/min/cm\^2; keep mean arterial pressure \> 65mmHg.

Treatment:

Other: hypotension prediction index(HPI)