NCT07109570 Surface Electrical Myography, Oxygen Consumption, Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit
| NCT ID | NCT07109570 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Critical Illness |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-07-08 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-07-08 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07109570 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07109570 currently recruiting?
Yes, NCT07109570 is actively recruiting participants. Contact the research team at a.schoe@lumc.nl for enrollment information.
Where is the NCT07109570 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT07109570 clinical trial?
NCT07109570 is sponsored by Leiden University Medical Center. The trial plans to enroll 60 participants.