Surface Electrical Myography, Oxygen Consumption, Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit

The goal of this observational study is to measure effort using esophageal pressure measurements, oxygen consumption and diaphragm activity in mechanically ventilated Intensive Care Unit patients during a Spontaneous Breathing Trial. The main question aims to answer whether the sEMG signal derived from the SERA device, effort parameters and oxygen consumption have an association with weaning failure. Participants will be measured while performing a spontaneous breathing trial.

NCT Number	NCT07109570
Lead Sponsor	Leiden University Medical Center Collaborators: Demcon-Macawi
Conditions	Critical Illness, Intensive Care Units (ICUs), Weaning Failure, Mechanical Ventilation, Spontaneous Breathing Trial, Diaphragm Electrical Activity, Oxygen Consumption
Enrollment	60 participants
Start Date	2025-07-08
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-06 (estimated)
Updated on ClinicalTrials.gov	2025-11-26