Clinical trial NCT06888180: Survey on NIV Settings in the Intensive Care Unit for Acute Exacerbation of COPD
Official title: Survey on Non-Invasive Ventilation Settings in the Intensive Care Unit for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Acute Exacerbation of COPD
Hypercapnic Respiratory Failure, COPD
Keywords: COPD
Acute exacerbation of COPD
Non invasive ventilation
Hypercapnic respiratory failure
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 976
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD Patients Admitted to Critical Care for Hypercapnic Respiratory Distress

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).


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

Primary outcomes:
measure: Ventilatory Settings at Initiation of Non-Invasive Ventilation Upon ICU Admission
timeFrame: Upon ICU admission
Secondary outcomes:
measure: Ventilatory Settings at Initiation of Non-Invasive Ventilation at 24h of ICU Admission
timeFrame: 24hours from ICU admission
measure: Ventilatory Settings at 48 Hours After Initiation of Non-Invasive Ventilation in the ICU
timeFrame: 48hours after ICU admission
measure: arterial blood gaz
timeFrame: Upon ICU admission, 24hours after ICU admission, 48hours after admission
measure: Mortality
timeFrame: at 28 days
Other outcomes:
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