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

Официальное название

Survey on Non-Invasive Ventilation Settings in the Intensive Care Unit for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Обзор

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).

Вмешательства

• Другое Non interventional study
  Documentation of Non-Invasive Ventilation Settings at Different Stages of Patient Management"

Первичные конечные точки

• Ventilatory Settings at Initiation of Non-Invasive Ventilation Upon ICU Admission [Срок оценки: Upon ICU admission]

Вторичные конечные точки (4)

• Ventilatory Settings at Initiation of Non-Invasive Ventilation at 24h of ICU Admission [Срок оценки: 24hours from ICU admission]
• Ventilatory Settings at 48 Hours After Initiation of Non-Invasive Ventilation in the ICU [Срок оценки: 48hours after ICU admission]
• arterial blood gaz [Срок оценки: Upon ICU admission, 24hours after ICU admission, 48hours after admission]
• Mortality [Срок оценки: at 28 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06888180 · 2024120510170200000180001753

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗