Clinical trial NCT05024838: Prediction of Block Height of Spinal Anesthesia
Official title: Prediction of Block Height of Spinal Anesthesia Via Machine Learning Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia; Reaction
Keywords: Spinal anesthesia, Machine learning, Sensory blockade
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2021-08-27
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving spinal anesthesia due to the need for surgical intervention with available electronic medical records.

Brief summary: Spinal anesthesia is one of the most used techniques for surgery. Anesthesiologists usually check the block height (dermatome) of spinal anesthesia before surgery start. More than 20 factors have been postulated to alter spinal anesthetic block height. We would like to use machine learning to comprehensively consider various factors such as physiological parameters and different drug characteristics to establish a predictive model to evaluate the sensory blockade of spinal anesthesia.

Detailed description: This is an observational study of the retrospective collection of patient data.

The investigators retrospectively collected the electronic medical record of patients receiving spinal anesthesia from July 1, 2018, to Dec 31, 2018. Anesthesia-related factors such as anesthesiologist's expertise, injection site, patient position, the dosage of local anesthetics, needle size, the direction of needle bevel, and basic demographic information of the patients were used for data analysis. Patients less than 18 years old were excluded from this study. Twenty percent of the dataset was used as a testing dataset, and the remaining were used for model training. The investigators will utilize four machine learning algorithms as XGBoost (Extreme Gradient Boosting), AdaBoost (Adaptive Boosting), Random Forest (RF), and support vector machine (SVM). Model performances were evaluated visually with a confusion matrix.

Eligibility criteria: Inclusion Criteria:

* Patients receiving spinal anesthesia from July 1, 2018, to Dec 31, 2018, with available electronic medical records.

Exclusion Criteria:

* Age \<18 years

Primary outcomes:
measure: Sensory blockade height of spinal anesthesia
timeFrame: From time of starting spinal anesthesia until the time of testing blockage height, assessed up to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesiology, Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veteran General Hospital, Taiwan
name: Hung-Wei Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Greene NM. Distribution of local anesthetic solutions within the subarachnoid space. Anesth Analg. 1985 Jul;64(7):715-30. No abstract available.
citation: Horstman DJ, Riley ET, Carvalho B. A randomized trial of maximum cephalad sensory blockade with single-shot spinal compared with combined spinal-epidural techniques for cesarean delivery. Anesth Analg. 2009 Jan;108(1):240-5. doi: 10.1213/ane.0b013e31818e0fa6.
citation: Kozanhan B, Bardak O, Sami Tutar M, Ozler S, Yildiz M, Solak I. The influence of Body Roundness Index on sensorial block level of spinal anaesthesia for elective caesarean section: an observational study. J Obstet Gynaecol. 2020 Aug;40(6):772-778. doi: 10.1080/01443615.2019.1647523. Epub 2019 Aug 30.
citation: Kuok CH, Huang CH, Tsai PS, Ko YP, Lee WS, Hsu YW, Hung FY. Preoperative measurement of maternal abdominal circumference relates the initial sensory block level of spinal anesthesia for cesarean section: An observational study. Taiwan J Obstet Gynecol. 2016 Dec;55(6):810-814. doi: 10.1016/j.tjog.2015.04.009.