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Patient-Ventilator Dyssynchrony Detection With a Machine Learning Algorithm

Automated Detection and Classification of Patient-Ventilator Dyssynchrony With a Machine Learning Algorithm

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06506123
Enrollment
80
Registered
2024-07-17
Start date
2024-05-25
Completion date
2025-12-24
Last updated
2024-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

mechanical ventilation, artificial intelligence

Brief summary

This is a diagnostic study aiming to compare accuracy to detect and classify patient-ventilator dyssynchronies by a machine learning algorithm, compared to the gold-standard defined as dyssynchronies diagnosed and classified by mechanical ventilator and esophageal pressure waveforms analyzed by experts. The main question of this study is: • Are patient-ventilator dyssynchronies accurately detected and classified by an artificial intelligence algorithm when compared to experts analyzing esophageal pressure and mechanical ventilator waveforms?

Detailed description

This is a diagnostic, observational study, aiming to assess patient-ventilator dyssynchrony automated detection and classification by a machine learning algorithm. Accuracy of the machine learning algorithm will be compared with the gold-standard, defined as dyssynchronies detected and classified by mechanical ventilation experts. Experts will analyzed airway pressure, flow, volume and esophageal pressure waveforms to detect and classify dyssynchronies.

Interventions

DEVICEArtificial Intelligence Detection and Classification of Patient-Ventilator Dyssynchronies

Machine learning algorithm to detect and classify patient-ventilator dyssynchronies, which is integrated in the mechanical ventilator (Fleximag Max, Magnamed, Brazil).

Sponsors

Magnamed Tecnologia Medica S/A
CollaboratorUNKNOWN
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Subjects under assisted or assist-controlled mechanical ventilation and monitored with esophageal pressure balloon.

Exclusion criteria

* Refusal from patient's family or attending physician

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Accuracy of the Artificial Intelligence algorithm3 daysSensitivity, specificity, positive predictive value, negative predictive value of the artificial intelligence algorithm to detect and classify patient-ventilator dyssynchronies. These accuracy indexes will be estimated for each kind of dyssinchrony: ineffective effort, autotriggering, double triggering, reverse triggering, reverse triggering with a double cycle

Secondary

MeasureTime frameDescription
Pendelluft detection3 daysPercentage of cycles with pendelluft detected with the artificial intelligence algorithm compared to the percentage of cycles with pendelluft detected with the esophageal pressure

Countries

Brazil

Contacts

Primary ContactGlauco M Plens, MD
glaucomplens@gmail.com+5511982213020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026