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

Recruiting now

Conditions studied: Critical Illness, Intensive Care Units (ICUs), Weaning Failure, Mechanical Ventilation, Spontaneous Breathing Trial, Diaphragm Electrical Activity, Oxygen Consumption

In brief

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.

Key facts

Study ID

NCT07109570

Run by

Leiden University Medical Center

People needed

60

Starts

2025-07-08

Expected to finish

2029-06-01

Last updated by the study team

2025-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Esophageal catheter in situ (standard of care)
• Eligible for an SBT in the near future according to the LUMC SBT protocol currently valid

You may not qualify if…

• Severe cardiac failure NYHA class IV without mechanical support (LVAD or Impella)
• COPD Gold IV
• Pregnancy
• Patients with ECMO

Where it is running

• Leiden University Medical Centre — Leiden, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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