Measuring breathing effort to improve lung and diaphragm health during ventilation
Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation
This study tests if measuring how hard patients breathe while on a ventilator can help keep their lungs and diaphragm healthy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 29 Days and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 3 sites (Edegem, Antwerp and 2 other locations) |
| Trial ID | NCT05459116 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective cohort trial involves adult and pediatric ICU patients requiring mechanical ventilation. The study aims to assess the impact of inspiratory effort on lung and diaphragm function by measuring esophageal pressures and conducting ultrasound evaluations over a maximum of 8 days. Investigators will use a nasogastric balloon catheter to quantify respiratory muscle function and hypothesize that minimal inspiratory effort will help preserve diaphragm function without harming lung health.
Who should consider this trial
Good fit: Ideal candidates include adults and children over 28 days old who are on invasive mechanical ventilation for more than 48 hours.
Not a fit: Patients who have had mechanical ventilation within the last two weeks or have anatomical malformations of the diaphragm may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved ventilation strategies that protect lung and diaphragm function in critically ill patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding respiratory mechanics and improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 28 days * weight \> 3kg * requiring invasive mechanical ventilation * anticipated length of ventilation \> 48h Exclusion Criteria: * refusal of consent * mechanical ventilation ≤ 2 weeks before inclusion * known anatomical malformation of the diaphragm (including congenital diaphragmatic hernia) * contra-indication to the placement of a naso-gastric esophageal balloon catheter
Where this trial is running
Edegem, Antwerp and 2 other locations
- Antwerp University Hospital (UZA) — Edegem, Antwerp, Belgium (Recruiting)
- University Hospital Leuven (UZL) — Leuven, Belgium (Recruiting)
- The Hospital for Sick Children (SickKids) — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Vertongen
- Email: icu-research@uza.be
- Phone: +323 821 44 04
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.