Evaluation by Electrical Impedancemetry of the Variation in Lung Volumes Under Non-invasive Venti… (NCT05953298) | Clinical Trial Compass
CompletedNot Applicable
Evaluation by Electrical Impedancemetry of the Variation in Lung Volumes Under Non-invasive Ventilation (NIV) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
France30 participantsStarted 2023-06-26
Plain-language summary
The aim of this physiologic research is to assess lung volumes variations under NIV in stable COPD patients to understand the impact of "high-intensity" ventilation following the current recommendations. The main objective is to evaluate the variation of End-expiratory lung volume (EELV) reflecting the functional residual capacity (FRC), via the End-tidal lung impedance (EELI) obtained by electrical impedance tomography during a 20 minutes NIV session.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with COPD in stable condition fitted with long-term NIV followed at Bordeaux University Hospital;
* Patient benefiting from social protection from the national health insurance fund;
* Patient having read the patient information letter and given his non-objection to participate in the study.
Exclusion Criteria:
* Obesity with a BMI \> 35;
* Respiratory exacerbation during treatment;
* Patient with one or more contraindications to the implementation of EIT(7):
* Pacemaker, defibrillator, electric active medical device;
* Damaged skin condition, dressing on the observation area;
* Risk related to fitting the belt (fracture, spinal lesions, etc.);
* Uncontrollable movements;
* Current electrotherapy;
* Presence of a magnetic field (magnetic resonance imaging);
* Other bioimpedance measurements in progress;
* Pregnant woman ;
* Tidal volume \< 1ml/kg;
* Patient having read the patient information letter and refusing to participate in the study (Loi Jardé research category 3);
* Patient under guardianship, curatorship, or deprived of freedom of administrative or judicial decision;
* Patient included in other protocols that may interact with this study;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
End-Expiratory Lung Impedance (EELI) evolution during NIV sessions