Prediction of Block Height of Spinal Anesthesia

NCT ID: NCT05024838

Last Updated: 2021-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-07-31

Brief Summary

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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

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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.

Conditions

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Anesthesia; Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Machine learning methods

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age \<18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hung-Wei Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veteran General Hospital, Taiwan

Locations

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Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hung-Wei Cheng, MD

Role: CONTACT

886-2-28757549

Facility Contacts

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Hung-Wei Cheng, MD

Role: primary

+886938593113

References

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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.

Reference Type BACKGROUND
PMID: 22476235 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25625258 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3893222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19095857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31469024 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28040125 (View on PubMed)

Other Identifiers

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2020-01-004CC

Identifier Type: -

Identifier Source: org_study_id

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