Prediction of Block Height of Spinal Anesthesia

NCT05024838 | Unknown

• 1 other identifier: 2020-01-004CC
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Reaction

Keywords

Spinal anesthesia, Machine learning, Sensory blockade

Outcome Measures

Primary Outcomes (1)

• Sensory blockade height of spinal anesthesia

  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.

  From time of starting spinal anesthesia until the time of testing blockage height, assessed up to 10 minutes

Study Arms (1)

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

Interventions

Machine learning methods OTHER

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.

Spinal anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving spinal anesthesia due to the need for surgical intervention with available electronic medical records.

You may qualify if:

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

You may not qualify if:

• Age \<18 years

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Related Publications (6)

• Fanning N, Arzola C, Balki M, Carvalho JC. Lumbar dural sac dimensions determined by ultrasound helps predict sensory block extent during combined spinal-epidural analgesia for labor. Reg Anesth Pain Med. 2012 May-Jun;37(3):283-8. doi: 10.1097/AAP.0b013e31824b30d2.

  PMID: 22476235 BACKGROUND

• Heng Sia AT, Tan KH, Sng BL, Lim Y, Chan ESY, Siddiqui FJ. Hyperbaric versus plain bupivacaine for spinal anesthesia for cesarean delivery. Anesth Analg. 2015 Jan;120(1):132-140. doi: 10.1213/ANE.0000000000000443.

  PMID: 25625258 BACKGROUND

• Greene NM. Distribution of local anesthetic solutions within the subarachnoid space. Anesth Analg. 1985 Jul;64(7):715-30. No abstract available.

  PMID: 3893222 BACKGROUND

• 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.

  PMID: 19095857 BACKGROUND

• 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.

  PMID: 31469024 BACKGROUND

• 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.

  PMID: 28040125 BACKGROUND

Study Officials

• Hung-Wei Cheng, MD

  Taipei Veteran General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Wei Cheng, MD

CONTACT

886-2-28757549; hwc1127@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 27, 2021
• Study Start: October 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

TW (1)