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

NCT ID: NCT06888180

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 976 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-09-30

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).

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD patients managed with NIV during acute exacerbation

Non interventional study

Intervention Type: OTHER

Documentation of Non-Invasive Ventilation Settings at Different Stages of Patient Management"

Interventions

Non interventional study

Documentation of Non-Invasive Ventilation Settings at Different Stages of Patient Management"

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Pierre Cuchet, Medical degree

Role: CONTACT

cuchet-p@chu-caen.fr

+33231065318

Other Identifiers

2024120510170200000180001753

Identifier Type: -

Identifier Source: org_study_id