Prediction of Block Height of Spinal Anesthesia

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05024838
Collaborator
(none)
3,000
1
21
143.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Machine learning methods

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Prediction of Block Height of Spinal Anesthesia Via Machine Learning Approach
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Spinal anesthesia

The investigators retrospectively collected the electronic medical record of patients receiving spinal anesthesia from July 1, 2018, to Dec 31, 2018. Patients less than 18 years old were excluded from this study.

Other: Machine learning methods
This is an observational study of the retrospective collection of patient data. 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.

Outcome Measures

Primary Outcome Measures

  1. Sensory blockade height of spinal anesthesia [From time of starting spinal anesthesia until the time of testing blockage height, assessed up to 10 minutes]

    The record of sensory blockade level was extracted from retrospective electronic medical records as the primary outcome. The investigators would like to use machine learning methods to consider various factors such as physiological parameters of patients, different drug characteristics, and different anesthesia providers to establish a predictive model to evaluate the sensory blockade of spinal anesthesia.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients receiving spinal anesthesia from July 1, 2018, to Dec 31, 2018, with available electronic medical records.
Exclusion Criteria:
  • Age <18 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology, Taipei Veterans General Hospital Taipei Taiwan 112

Sponsors and Collaborators

  • Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Hung-Wei Cheng, MD, Taipei Veteran General Hospital, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT05024838
Other Study ID Numbers:
  • 2020-01-004CC
First Posted:
Aug 27, 2021
Last Update Posted:
Aug 27, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Taipei Veterans General Hospital, Taiwan

Study Results

No Results Posted as of Aug 27, 2021