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Study of Surface Electrical Myography and Oxygen Use to Understand Breathing Effort and Weaning in ICU Patients on Mechanical Ventilation
Led by Leiden University Medical Center · Updated on 2025-11-26
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of surface electromyography sEMG derived from the SERA device to measure respiratory muscle activity, oxygen use, and effort in patients in the Intensive Care Unit who are mechanically ventilated. The study aims to find out if these measurements can help predict weaning failure, where patients struggle to stop ventilator support and may need re-intubation shortly after. This observational study focuses on patients undergoing spontaneous breathing trials to assess their readiness for extubation. Participants will be monitored starting 10 minutes before their spontaneous breathing trial SBT, continuing throughout the trial, and for 10 minutes after it ends. The study collects data from the SERA device, mechanical ventilator, and oxygen consumption monitors, focusing on various effort parameters including diaphragm electrical activity and breathing workload. No treatments or interventions are given, as this is a data collection study. During the study, participants will have measurements taken of diaphragm electrical signals, oxygen use, esophageal pressures, and breathing patterns related to effort and work of breathing. Researchers will observe these measures before, during, and after the SBT. The main outcome is whether these signals are linked to extubation failure within 48 hours. The study imposes minimal burden or risk, as it does not alter standard care and only involves monitoring. Participants remain under usual medical care throughout the study duration.
CONDITIONS
Brief Title
Surface Electrical Myography, Oxygen Consumption, Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit
Research Team
A
Abraham Schoe, MD, PhD
F
Florence E Smits, MSc
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