Predicting Neuromuscular Recovery in Surgical Patients Using Machine Learning

Postoperative Complications Clinical Trial

— PINES  

Official title:

Development and Validation of a Machine Learning Algorithm for Prediction of Complete Neuromuscular Recovery in Adult Surgical Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05471882
• Other study ID #: TOF-R Prediction
• Status: Not yet recruiting
• Start date: November 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: July 2022
• Source: University Hospital Ulm
• Contact: Flora Scheffenbichler, MD
• Phone: 004973150060284
• Email: flora.scheffenbichler[@]uni-ulm.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Despite emerging efforts to decrease residual paralysis and postoperative complications with the use of quantitative neuromuscular monitoring and reversal agents their incidences remain high. In an optimal setting, neuromuscular blocking agents are dosed in a way that there is no residual block at the end of surgery. The effect of neuromuscular blocking agents, however, is highly variable and is not only influenced by their dose, but also by several patient-related factors such as muscle status, metabolic activity, and anesthesia management. Accordingly, the duration of action is difficult to predict.

The PINES project will use artificial intelligence methods to develop a model that can accurately predict the course of action of neuromuscular blocking agents. It will be used to predict time to complete neuromuscular recovery (train-of-four [TOF] ratio >0.95) and may provide as a decision support in the individual management of timing and dosing of neuromuscular blocking drugs and their reversal agents.

Description:

The objective of the PINES project is to identify a model that can accurately predict 1) time to complete neuromuscular recovery, 2) optimal timing and dose of neuromuscular blocking agents at each time point during surgery, and 3) TOF ratio at the estimated end of surgery to assess residual paralysis. Furthermore, a prospective clinical pilot study will be conducted to compare anesthesiologist-predicted neuromuscular recovery with that of the algorithm.

The project consists of two main objectives:

I. Big data analysis

• Establishing a data warehouse: Electronic registry data will be used.

• Generation of prediction models: Classification models will first be used to identify and weight the relevant parameters collected during premedication and intraoperatively. These will form the basis for the training cohort, which can then be used to carry out a simulated real-time analysis of the data. To compare the models, the loss functions mean squared error, mean absolute error and Huber Loss will be calculated.

II. Prospective comparison of the prediction: machine-learning model vs. anesthesiologist

Using the validated final prediction model with the best accuracy, we will perform a prospective clinical pilot study. The cohort will include prospectively enrolled surgical patients which will be analysed by the prediction model as well as an experienced anesthesiologist. Surgeries requiring neuromuscular block of any non-depolarising neuromuscular blocking agent will be included. An anesthesiologist will prospectively estimate the time to neuromuscular recovery in 10-minute intervals beginning with the initial dose of neuromuscular blocking agent administration at anesthesia induction. Agreement between predictions and objectively measured time to TOF ratio >0.95 will be assessed using inter-rater correlation coefficients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240000
• Est. completion date: April 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (=18 years) undergoing non-cardiac surgery receiving general anesthesia with intraoperative neuromuscular blocking agent administration and available TOF data.

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Neuromuscular Blockade
• Paralysis
• Postoperative Complications
• Residual Paralysis, Post Anesthesia

Locations

Country	Name	City	State
Germany	Technical University Munich	Munich	Bavaria
Germany	University Hospital Ulm	Ulm	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Ulm	Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete neuromuscular recovery	predicting the time to complete neuromuscular recovery (defined as TOF ratio >0.95) from any time point of surgery	intraoperative