Clinical trial NCT05117151: Ability of Hypotension Prediction Index to Predict Hypotension Events in Thoracic Surgery
Official title: Ability of Hypotension Prediction Index to Predict Future Hypotension Events in Each Phase of Thoracic Surgery: an Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative/Postoperative Complications
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults undergoing scheduled VATS surgery

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: ability of hypotension prediction index in predicting hypotension events
timeFrame: 3 hours
Secondary outcomes:
measure: ability of dynamic parameters in predicting hypotension events
timeFrame: 3 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Yu Wu, Ph.D.
role: STUDY_CHAIR
References:
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.
citation: 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.0000000000002300.
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 Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.