NCT05820347

Muscle Pressure Estimation With Artificial Intelligence During Mechanical Ventilation

Validation of Inspiratory Muscle Pressure Estimation and Automated Detection of Asynchronies in Patients Under Assisted Mechanical Ventilation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this diagnostic study is to validate estimation of inspiratory muscle pressure by an artificial intelligence algorithm compared to the gold standard, the measure from an esophageal catheter balloon, in patients under assisted mechanical ventilation. The main questions it aims to answer are: • Are inspiratory muscle pressure estimates from an artificial intelligence algorithm accurate when compared to the direct measure from an esophageal balloon? Participants will be monitored with an esophageal balloon and with an artificial intelligence algorithm simultaneously, with inspiratory muscle pressure estimation during assisted mechanical ventilation with decremental levels of pressure support.

Detailed description

This is a diagnostic study to validate estimation of inspiratory muscle pressure during assisted ventilation from an artificial intelligence algorithm integrated in a mechanical ventilator (FlexiMag, Magnamed, Brazil) compared to direct measure of muscle pressure from esophageal catheter balloon (gold standard). This is a novel non-invasive method to estimate inspiratory muscle pressure. After obtaining informed consent, participants will be monitored simultaneously with the esophageal balloon and the artificial intelligence algorithm, with decremental levels of pressure support (20 to 2 cmH2O, in steps of 20 minutes). Esophageal balloon will be removed after completing the last pressure support step. The investigators estimated a sample of 50 participants, considering 3 cmH2O as a clinically relevant discordance between methods and 10% of missing data. Concordance analysis and correlation analysis will be performed. Procedures will follow a specific Standard Operating Procedures and participants inclusion data will be inserted in REDCap.

Conditions

• Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation	Estimation of inspiratory muscle pressure by an artificial intelligence algorithm integrated in the mechanical ventilator (FlexiMag, Magnamed, Brazil).

Timeline

• Start date: 2022-08-26
• Primary completion: 2023-07-18
• Completion: 2023-07-18
• First posted: 2023-04-19
• Last updated: 2023-09-06

Locations

1 site across 1 country: Brazil