Ability of Hypotension Prediction Index to Predict Hypotension Events in Thoracic Surgery

Perioperative/Postoperative Complications Clinical Trial

Official title:

Ability of Hypotension Prediction Index to Predict Future Hypotension Events in Each Phase of Thoracic Surgery: an Observational Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05117151
• Other study ID #: 202109061RIND
• Status: Active, not recruiting
• Start date: March 23, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators design this prospective observational study to exam the ability of hypotension prediction index in predicting intraoperative hypotension events in each phase of thoracic surgery

Description:

Hypotension prediction index is a novel introduced monitoring-tool that aims to predict hypotension events before their occurence, and has been reported to have superior predictive ability than the commonly measured perioperative hemodynamic variables. To date, there is no information regarding its ability to predict hypotension events in each phase of thoracic surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• adults undergoing scheduled VATS surgery

Exclusion Criteria:

• pregnant women
• patients in intensive care units
• patients with the underlying disease including respiratory failure(FEV1/FVC < 70 % and FEV1 < 50%), heart failure(NYHA score =III?IV), kidney failure(eGFR< 60 ml.min-1.1.73m-2), liver failure
• patients with ongoing infection

Related Conditions & MeSH terms

• Hypotension
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Diagnostic Test:
• hypotension prediction index
monitor intraoperative hypotension prediction index as well as hemodynamic variables to exam the ability in predicting hypotension events of each variable

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 (3)

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. Anesthesi — 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
Primary	ability of hypotension prediction index in predicting hypotension events	to calculate the sensitivity/specificity and AUROC of hypotension prediction index in predicting hypotension events	3 hours
Secondary	ability of dynamic parameters in predicting hypotension events	to calculate the sensitivity/specificity and AUROC of dynamic parameters in predicting hypotension events	3 hours