Monitoring diaphragm electrical activity and breathing effort during ventilator weaning
Official title: Surface Electrical Myography, Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU): SERA-Effort Study
Run by Leiden University Medical Center · NCT07109570 · Data updated 2026-11-12
We will see if surface diaphragm EMG, esophageal pressure, and oxygen use measured during a spontaneous breathing trial can predict who will fail to wean from the ventilator in the ICU.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden) |
| Status | Recruiting |
| Started | July 8, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | June 2029 |
| Registry record updated | November 26, 2025 |
| Trial ID | NCT07109570 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults on mechanical ventilation who are eligible for a spontaneous breathing trial and have an esophageal catheter in place are the intended participants.
✕Probably not a fit
Patients without an esophageal catheter, pregnant people, and those with ECMO, severe cardiac failure (NYHA IV without support), or COPD Gold IV are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study that records diaphragm surface electromyography (sEMG) using the SERA device, esophageal pressure (effort), and oxygen consumption in mechanically ventilated ICU patients during a spontaneous breathing trial (SBT). Measurements are taken while patients undergo an SBT as part of routine care; no experimental treatment is given. The main question is whether the sEMG signal, effort parameters, and oxygen consumption are associated with SBT failure or extubation failure within 48 hours, and whether these metrics improve on the rapid shallow breathing index (RSBI). Data will be analyzed to explore correlations between the signals and clinical weaning outcomes.
Why it matters
Potential benefit: If successful, this could give clinicians a better way to predict extubation failure and reduce the number of re-intubations.
How similar studies have gone: Previous work shows diaphragm EMG correlates with diaphragmatic force and diaphragm dysfunction links to weaning failure, and the SERA device is under investigation in neonates, but use of surface EMG to predict adult extubation outcomes is not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Severe cardiac failure NYHA class IV without mechanical support (LVAD or Impella) * COPD Gold IV * Pregnancy * Patients with ECMO
Where it's running
-
Leiden University Medical Centre
Leiden, Netherlands Recruiting
Study contacts
- Study coordinator: Abraham Schoe, MD, PhD
- Email: a.schoe@lumc.nl
- Phone: +31715265018
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.