Etude Clinique Observationnelle, Prospective, Ouverte, Monocentrique Sur l'Utilisation d'un Mode Ventilatoire entièrement automatisé Chez Les Patients de réanimation de l'Intubation Jusqu'au Sevrage.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- oxygenation , gaseous interchange and ventilation parameters
研究概览
简要总结
Rational: Intellivent is a ventilation mode completely automated which controls ventilation and oxygenation parameters. Safety and performance of IntelliVent has still been demonstrated in post operative heart surgery for patient with a controlled ventilation on short period (2 to 4 hours). This feasibility study evaluate the use of Intellivent for Intensive care unit patients from intubation to coming off.
Primary objective : Compare parameters which have been selected by automated mod (Intellivent) to those selected by clinical practitioner in a conventional mode
Secondary objectives: Record oxygenation , gaseous interchange and ventilation parameters. Record complications, number of manual adjustments and prognostic signs.
Methodology: Patients in the intensive care unit who need invasive ventilation. They will be included after a detailed information (information note). Oxygenation and ventilation parameters will be recorded 2 times by day from intubation to coming off. The investigator in charge will determine daily at the bedside of the patient the adjustments he should make in a conventional mode. These adjustments will be compared to the IntelliVent automated adjustments.
Experimental study, observational, prospective, comparative, opened, monocentric in an intensive care unit.
Number of patients: 100
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient which needs an invasive ventilation
- •Intubation < 24 hours
- •Age ≥ 18 years
排除标准
- •Patient which has withdrawal standard in line with the unit coming off procedure (all criteria must be present)
- •temperature ≤ 38,5°C
- •No pressor drug
- •No sedation,
- •Motor response to order,
- •Cough during bronchoaspiration
- •%VM ≤ 130%, FiO2 ≤ 50%, PEEP ≤ 5 cmH2O, Pinsp ≤ 25 cmH2O.
- •Patient with non invasive ventilation .
- •Dysfunctions of the ventilatory command (ex Cheyne-Stokes).
- •Broncho pleural fistula.
- •Brain dead status.
- •Pregnant woman.
- •Adult under guardianship.
- •Person deprived of liberty
结局指标
主要结局
oxygenation , gaseous interchange and ventilation parameters
时间窗: Participants are followed until they no longer need ventilation up to 10 days
Record oxygenation , gaseous interchange and ventilation parameters
次要结局
未报告次要终点