NCT05953298Completed
Evaluation by Electrical Impedancemetry of the Variation in Lung Volumes Under Non-invasive Ventilation (NIV) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Evaluation by Electrical Impedancemetry of the Variation of Lung Volumes Under NIV in Patients With COPD
Source: ClinicalTrials.gov · Last updated 26 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 11 Jul 2023
- Start date
- 26 Jun 2023
- Primary completion date
- 28 May 2024
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- COPD
- NCT number
- NCT05953298
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 26 Jun 2023 to the primary completion date, 28 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Other
- Obesity with a BMI \> 35;
- Respiratory exacerbation during treatment;
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Haut Lévêque, Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.