NCT06888180Not yet recruiting
Survey on NIV Settings in the Intensive Care Unit for Acute Exacerbation of COPD
Survey on Non-Invasive Ventilation Settings in the Intensive Care Unit for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov · Last updated 26 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Introduction Chronic obstructive pulmonary disease (COPD) is a common condition and the fourth leading cause of death worldwide. With the rise of non-invasive ventilation (NIV), mortality among patients admitted for acute hypercapnic respiratory failure has decreased, though to a lesser extent than reported in the studies that validated this technique. We hypothesize that inappropriate initial ventilatory parameter settings for NIV could be associated with increased morbidity and mortality in this context. Objective The primary objective of this study is to assess the initial NIV settings used in intensive care units (ICUs) and respiratory intensive care or medical intensive care units (MICUs) in this patient population. A secondary objective is to evaluate whether specific ventilatory settings are associated with mortality or the need for invasive mechanical ventilation (IMV). Methods This is a prospective multicenter observational study aiming to include 976 patients. NIV settings will be recorded at initiation, after the first recommended arterial blood gas (ABG) evaluation (between 1.5 and 2 hours of ventilation), and at 24 and 48 hours. Patient characteristics, including medical history, clinical and biological parameters at admission, will be collected. Vital status and the need for IMV will be recorded at ICU discharge and on day 28 (D28).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 976 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- Sept 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- University Hospital, Caen
- Diseases
- COPD
- NCT number
- NCT06888180
What you commit to
- Study type: Observational
- Planned participants: 976
- From Sept 2025 to the primary completion date, Sept 2027
- No sites listed in no 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
- Other obstructive diseases (asthma, bronchiectasis, cystic fibrosis, bronchiolitis, pulmonary fibrosis, restrictive thoracic syndrome) Central hypoventilation (Ondine's syndrome, iatrogenic), neurological (neuromuscular disease), osteoarticular (kyphoscoliosis), or ENT-related causes
- Contraindications to NIV (untreated pneumothorax, shock, cardiac arrest, uncontrolled vomiting, upper gastrointestinal bleeding, cervicofacial trauma, coma except when related to hypercapnia)
Other
- Pregnant or breastfeeding women
- Immediate need for intubation
- Acute pulmonary edema
- Patients under legal guardianship
- Incarcerated individuals
Who the study is looking for
- Adult COPD Patient
- Known or suspected COPD diagnosis as assessed by the attending physicians
- Admitted to a medical intensive care unit (MICU), respiratory intensive care unit, or MICU
- Hypercapnic respiratory distress
- NIV indication determined by the physician
- Covered by social security
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.