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

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-23

Study Completion Date

2024-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Orthopedic Disorder Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control group

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.

Group Type ACTIVE_COMPARATOR

ordinary goal-directed hemodynamic therapy

Intervention Type OTHER

Keep pulse pressure variation \>12%; keep cardiac index \>2L/min/cm\^2; keep mean arterial pressure \> 65mmHg.

HPI group

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.

Group Type EXPERIMENTAL

hypotension prediction index(HPI)

Intervention Type OTHER

Implementing hypotension prediction index (HPI) in perioperative goal-directed hemodynamic therapy. Keep HPI \< 85; pulse pressure variation \>12%; keep cardiac index \>2L/min/cm\^2; keep mean arterial pressure \> 65mmHg.

Interventions

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hypotension prediction index(HPI)

Implementing hypotension prediction index (HPI) in perioperative goal-directed hemodynamic therapy. Keep HPI \< 85; pulse pressure variation \>12%; keep cardiac index \>2L/min/cm\^2; keep mean arterial pressure \> 65mmHg.

Intervention Type OTHER

ordinary goal-directed hemodynamic therapy

Keep pulse pressure variation \>12%; keep cardiac index \>2L/min/cm\^2; keep mean arterial pressure \> 65mmHg.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No