Measuring breathing effort before and after removing the breathing tube
Inspiratory Work of Breathing Before and After Extubation
This will test a new electrical impedance method to measure breathing effort in adults on ventilators as they try breathing on their own and after the breathing tube is removed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 67 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07017608 on ClinicalTrials.gov |
What this trial studies
At Toronto General Hospital, adult patients who are intubated and pass readiness-to-wean screening will undergo spontaneous breathing trials using zero end-expiratory pressure (ZEEP) and CPAP at 5 cmH2O. Investigators will use electrical impedance tomography and, where appropriate, esophageal pressure monitoring to quantify inspiratory work of breathing before and after extubation. This is an observational protocol comparing breathing effort across SBT techniques and tracking immediate changes after removal of the endotracheal tube. Patients with contraindications to esophageal catheter insertion or to electrical impedance tomography are excluded.
Who should consider this trial
Good fit: Adults who are intubated, mechanically ventilated, and pass a readiness-to-wean screen at Toronto General Hospital are the intended participants.
Not a fit: Patients who cannot tolerate esophageal catheter placement, have thoracic skin issues preventing electrode placement, or are not candidates for extubation are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could help clinicians choose SBT settings that reduce breathing effort and lower the risk of failed extubation.
How similar studies have performed: Similar physiologic studies using esophageal pressure and electrical impedance tomography have described differences in work of breathing, but optimal SBT technique remains inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients intubated and ventilated Exclusion Criteria: * Contraindication for esophageal catheter insertion: upper gastrointestinal surgery within prior 6 weeks, actively bleeding esophageal varices * Bronchopleural fistula * Contraindication for electrical impedance tomography: chest burns, skin lesions in the thorax, chest wall bandaging limiting electrode placement, unstable spinal lesions or fractures * Pregnancy
Where this trial is running
Toronto, Ontario
- Toronto General Hospital, University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Ewan Goligher, MD — University Health Network, Toronto
- Study coordinator: Glauco Plens, MD
- Email: Glauco.Plens@uhn.ca
- Phone: 416-340-4800
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.