Postoperative Complications Clinical Trial
— PINESOfficial title:
Development and Validation of a Machine Learning Algorithm for Prediction of Complete Neuromuscular Recovery in Adult Surgical Patients
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Technical University Munich | Munich | Bavaria |
Germany | University Hospital Ulm | Ulm | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ulm | Technische Universität München |
Germany,
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 |
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