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

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05274412
• Other study ID #: 202112163RIND
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: April 2024

Study information

• Verified date: March 2022
• Source: National Taiwan University Hospital
• Contact: Chen-Tse Lee, MD
• Phone: 0972653169
• Email: lctbrian314[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemodynamic Instability
• Hypotension
• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Other:
• 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.
• ordinary goal-directed hemodynamic therapy
Keep pulse pressure variation >12%; keep cardiac index >2L/min/cm^2; keep mean arterial pressure > 65mmHg.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.00000000 — View Citation

Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756. Erratum In: Anesthesiology. 2016 Mar;124(3):741-2. — View Citation

Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20. — View Citation

Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intrao — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	perioperative neurocognitive disorder	Taiwan version of quick mild cognitive impairment(Qmci) test will be used to identify perioperative neurocognitive disorder	30 day
Primary	Perioperative acute kidney injury	Acute kidney injury will be assessed according to the KDIGO guideline. Serum creatinine will be examined on the day before surgery and postoperative day 1.	24 hours