Survey on NIV Settings in the Intensive Care Unit for Acute Exacerbation of COPD (NIV-ICU)

Caen University Hospital

Status: Not yet enrolling

Conditions: Hypercapnic Respiratory Failure, COPD; Acute Exacerbation of COPD; COPD (Chronic Obstructive Pulmonary Disease)

Treatments: Other: Non interventional study

Study type: Observational

Funder types: Other

Identifiers

NCT06888180

2024120510170200000180001753

Details and patient eligibility

About

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).

Enrollment: 976 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

976 participants in 1 patient group

COPD patients managed with NIV during acute exacerbation

Treatment:

Other: Non interventional study