Measuring lung overinflation with electrical impedance tomography in ventilated COPD patients
Pulmonary Overdistension Assessment With Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrom in Prone Position.
This project will use electrical impedance tomography to see if ventilated adults with moderate-to-severe COPD have uneven lung inflation or overdistension while on NIV or invasive ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier de la côte Basque Academic / other |
| Locations | 1 site (Bayonne, Centre Hospitalier de La Côte Basque) |
| Trial ID | NCT07090460 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll adults with moderate-to-severe COPD who require noninvasive or invasive mechanical ventilation and who can be monitored with an EIT belt. Continuous EIT recordings will be made during tidal ventilation and during clinician-directed PEEP titration; in intubated patients a low-flow pressure–volume maneuver with simultaneous EIT will be performed to derive one-lung PEEPi. Analyses will measure interlung insufflation delay and regional tidal distribution to detect asymmetry and overdistension between lungs. Data will be analyzed offline with dedicated software to reconstruct regional PV curves and estimate regional intrinsic PEEP.
Who should consider this trial
Good fit: Adults (≥18) hospitalized in the ICU with moderate or severe COPD (GOLD 3–4) who are receiving NIV or invasive mechanical ventilation and can be fitted with an EIT belt are ideal candidates.
Not a fit: Patients with contraindications to EIT (for example pacemakers or implantable defibrillators), bronchopleural leaks, inability to position the EIT belt, pregnant or breastfeeding women, or those under guardianship are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could help clinicians detect asymmetric overinflation and ventilator asynchronies so they can better tailor ventilator settings and potentially reduce complications.
How similar studies have performed: Previous work has shown EIT can map regional ventilation and detect overdistension, but using EIT to measure one-lung PEEPi and interlung insufflation delay in COPD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients hospitalized in the ICU and who suffered moderate or severe COP (Gold 3 and 4)), with respiratory acidosis under NIV or intubated, and equipped with EIT over the age of 18. Exclusion Criteria: * Broncho-pleural leaks * Pregnant or breastfeeding woman. * Guardianship or curatorship * Deprived of liberty * No health insurance * Impossibility to correctly position the EIT belt (e.g., dressings, chest drainage, etc.) * Contra indications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions)
Where this trial is running
Bayonne, Centre Hospitalier de La Côte Basque
- Centre Hospitalier Côte Basque — Bayonne, Centre Hospitalier de La Côte Basque, France (Recruiting)
Study contacts
- Study coordinator: Professor ROZE
- Email: hroze@ch-cotebasque.fr
- Phone: +33559443535
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.