Monitoring diaphragm electrical activity and breathing effort during ventilator weaning
Surface Electrical Myography, Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU): SERA-Effort Study
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden) |
| Trial ID | NCT07109570 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Leiden
- Leiden University Medical Centre — Leiden, Netherlands (Recruiting)
Study contacts
- Study coordinator: Abraham Schoe, MD, PhD
- Email: a.schoe@lumc.nl
- Phone: +31715265018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.