Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06888180 | NOT YET RECRUITING | COPD (Chronic Obstructive Pulmonary Disease)

Survey on NIV Settings in the Intensive Care Unit for Acute Exacerbation of COPD
Sponsor:

University Hospital, Caen

Brief Summary:

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).

Condition or disease

COPD (Chronic Obstructive Pulmonary Disease)

Acute Exacerbation of COPD

Hypercapnic Respiratory Failure, COPD

Intervention/treatment

Non interventional study

Study Type : OBSERVATIONAL
Estimated Enrollment : 976 participants
Official Title : Survey on Non-Invasive Ventilation Settings in the Intensive Care Unit for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Actual Study Start Date : 2025-09
Estimated Primary Completion Date : 2027-09
Estimated Study Completion Date : 2027-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
Exclusion Criteria
  • * Pregnant or breastfeeding women
  • * 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
  • * Immediate need for intubation
  • * Acute pulmonary edema
  • * Contraindications to NIV (untreated pneumothorax, shock, cardiac arrest, uncontrolled vomiting, upper gastrointestinal bleeding, cervicofacial trauma, coma except when related to hypercapnia)
  • * Patients under legal guardianship
  • * Incarcerated individuals
Survey on NIV Settings in the Intensive Care Unit for Acute Exacerbation of COPD

Location Details

NCT06888180

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found