Voices of Patients' Relatives to Support Weaning From Mechanical Ventilation in Patients With Severe Brain Injury - VOICE-WEANING, a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Rate of weaning failure
研究概览
简要总结
Patients with severe brain injuries, such as ischemic stroke and intracranial hemorrhage, frequently require mechanical ventilation. Weaning of stroke patients is complicated by impaired consciousness and respiratory drive. Higher rates of weaning failure and delayed extubation (≥ 48h) lead to ventilator associated pneumonia, higher mortality and necessity of tracheostomy.
Therefore, improving the weaning of stroke patients from mechanical ventilation is warranted to prevent ventilator-associated complications and eventually improve clinical outcomes.
This single-center, randomized, clinical trial aims at demonstrating that voices of patients' relatives support weaning from mechanical ventilation and reduce weaning failure in brain-injured patients.
详细描述
Methods: Adult ICU-patients with controlled mechanical ventilation ≥48h due to a neurological disease will be included in the intensive care unit. A predefined text - including information on the patient's condition and recurrent request to breath in and out - will be recorded as an audio file by one of the patient's relatives. Patients will be randomly assigned in a 1:1 ratio to the conventional treatment arm or the Voice-Weaning arm. In the conventional arm, audio recordings will be muted by an independent person resulting in a mute recording without audio signals.
When conversion from controlled to assisted mechanical ventilation is intended according to standard treatment, audio recordings will be administered in repeat mode for 10 minutes and performed three times per day. If spontaneous breathing trials (SBT) are intended according to standard treatment, the audio recordings will be played during the SBT three times per day.
Criteria for weaning not to be intended - according to Boles et al. (Weaning from mechanical ventilation. Eur Respir J. 2007) and adapted to neurological patients:
Objective measurements:
- Unstable clinical condition
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Intubation and controlled mechanical ventilation ≥48h due to a neurological disease
- •Weaning from mechanical ventilation intended by the attending physician
- •Obtained informed consent from the legal representative
排除标准
- •Age < 18 years
- •History of psychiatric disease
- •Weaning from mechanical ventilation not intended or decision to limit therapeutic interventions
研究组 & 干预措施
Conventional arm
Muted audio recordings of the patients relatives.
干预措施: Sham control (Other)
Voice-Weaning arm
Audio recordings of the patients relatives including information on the patient's condition and recurrent request to breath in and out.
干预措施: Voice-Weaning (Other)
结局指标
主要结局
Rate of weaning failure
时间窗: first 28 days after start of ventilation, or until 48 hours after extubation, or discharge from intensive care, whichever came first
Reintubation and/or resumption of ventilatory support following extubation or death following extubation or failed spontaneous breathing trial
次要结局
- Rate of tracheotomy(first 28 days after start of ventilation or discharge from intensive care, whichever came first)
- All cause mortality rate at 90 days(first 90 days after start of ventilation)
- Time of controlled ventilation(first 28 days after start of ventilation or discharge from intensive care, whichever came first)
- Rate of ICU delirium(first 28 days after start of ventilation or discharge from intensive care, whichever came first)
研究者
Hagen B. Huttner
Principal Investigator
University of Erlangen-Nürnberg Medical School