Survey on Non-Invasive Ventilation Settings in the Intensive Care Unit for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 976
- 主要终点
- Ventilatory Settings at Initiation of Non-Invasive Ventilation Upon ICU Admission
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Ventilatory Settings at Initiation of Non-Invasive Ventilation Upon ICU Admission
时间窗: Upon ICU admission
次要结局
- Mortality(at 28 days)
- Ventilatory Settings at Initiation of Non-Invasive Ventilation at 24h of ICU Admission(24hours from ICU admission)
- Ventilatory Settings at 48 Hours After Initiation of Non-Invasive Ventilation in the ICU(48hours after ICU admission)
- arterial blood gaz(Upon ICU admission, 24hours after ICU admission, 48hours after admission)