Using diaphragm electrical signals (sEMG) to guide timing of breathing tube removal
Using sEMG of the Diaphragm to Assess Readiness for Extubation - Feasibility Study to Design a Pragmatic Multi-site Trial Protocol
This study will test whether surface electrodes that record diaphragm muscle activity can help doctors decide if adult ICU patients on a ventilator for more than 72 hours are ready to have their breathing tube removed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiff and Vale University Health Board Government |
| Locations | 1 site (Cardiff) |
| Trial ID | NCT07110129 on ClinicalTrials.gov |
What this trial studies
This observational project records surface electromyography (sEMG) from the diaphragm in adult ICU patients who have been mechanically ventilated for over 72 hours and are scheduled for an extubation attempt. Surface electrodes placed on the chest will capture respiratory muscle activity during spontaneous-breathing trials and the extubation process while usual clinical weaning and extubation protocols are followed. Investigators will link sEMG signal patterns to outcomes such as successful extubation versus need for reintubation to identify features associated with readiness. The data collection does not alter routine care but aims to determine whether sEMG could add objective information to current decision-making.
Who should consider this trial
Good fit: Adults in the ICU who have been mechanically ventilated for more than 72 hours and have an extubation attempt planned are the intended participants.
Not a fit: People under 18, patients with traumatic or spontaneous brain injury, those undergoing palliative extubation, or anyone with contraindications to sEMG (for example pacemakers, defibrillators, or skin lesions at electrode sites) are not expected to benefit or to be eligible.
Why it matters
Potential benefit: If successful, this approach could help clinicians better time extubation, potentially shortening ventilator duration and reducing reintubation and ICU stay.
How similar studies have performed: Prior small studies and work using diaphragmatic electrical monitoring (including esophageal EAdi and surface EMG) have shown promising signals but evidence remains limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients requiring mechanical ventilation for \>72 hours * Patients who an attempt at extubation is planned * Patients who are willing or able to give informed consent (Where consultee advice is sought, informed consent from the participant will be completed as soon as possible). Exclusion Criteria: * Aged under 18 years * Patients admitted with traumatic or spontaneous brain injury * Patients for who extubation is planned as a palliative process * Contra-indication to using sEMG e.g., permanent or temporary pacemaker, internal or external cardiac defibrillator, skin lesions around site of electrode placement
Where this trial is running
Cardiff
- Cardiff and Vale University Health Board — Cardiff, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Paul Twose, PhD
- Email: paul.twose@wales.nhs.uk
- Phone: +447739315830
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.