NL-OMON33002撤回不适用
Mechanical ventilation comparing high versus low tidal volumes in infants with or without acute lung injury. - Mechanical ventilation comparing high versus low tidal volumes in infants.
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •1. Children between the age of 2 months and 2 years admitted to the PICU and requiring MV with ALI and non ALI.
- •ALI is defined as:
- •- Bilateral infiltration seen on frontal chest radiograph
- •- No clinical evidence of left atrial hypertension
- •- Partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio of less than 300 mmHg
- •2. Patients on ventilatory support not exceeding 72 hours before inclusion of the study.
- •3. The expected duration of ventilation should be minimal 24 hours.
- •4. Patients should be ventilated by the Pressure Regulated Volume Controle (PRVC) mode.
排除标准
- •No informed consent from the patient*s legal representative
- •Expected survival < 2 days
- •Infants < 2 months of age and infants > 2 years
- •Use of corticosteroids < 6 weeks before the start or during the study
- •Immunocompromised patients
- •Critical pulmonary or cardiac function documented by an FiO2/PaO2 ratio
- •< 100 mmHg or need of catecholamines for inotropic support
- •defined as norepinephrine > 0.5 microgram/kg/min in spite of adequate fluid
- •resuscitation
- •Pneumothorax proven by chest X-ray.
- •Severe chest deformations (open sternum, flial chest, kyphoscoliosis)
- •Chronic hypoxemic lung disease
- •Cyanotic congenital heart disease
- •Cardiac failure as a primary cause of lung disease
- •Patients who had received a bone marrow or lung transplantation
- •Patients with increased intracranial pressure
- •Patients who had participated in other clinical trials involving acute lung
- •injury within the preceding 30 days.
- •Severe chronic liver disease (as defined by Child-Pugh class C)
- •Patients after cardiac resuscitation
- •Patients with a decision to limit life support.
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