A Randomised Feasibility Study Examining Neurally-adjusted Ventilatory Assist (NAVA) in Patients at High Risk of Prolonged Ventilatory Failure During Recovery From Critical Illness.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Protocol compliance
研究概览
简要总结
Many patients admitted to intensive care have heart or lung problems. Patients with these conditions often require longer durations of support from breathing machines. Survival and long-term recovery are improved if the investigators can remove the breathing support quickly. In this study, the investigators will focus on patients with severe lung or heart disease to examine whether a particular type of breathing machine (NAVA ventilator) will allow us to remove breathing support more quickly and with less need for sedative medications, when compared to current practice.
详细描述
In this study, we will compare the use of Neurally Adjusted Ventilatory Assist technology (the NAVA ventilation mode and the monitoring capabilities) against standard care in patients who are at risk of prolonged periods of mechanical ventilation.
Study aim
To inform the design of a definitive randomised controlled trial (RCT) by undertaking feasibility testing, evaluation of the proposed NAVA intervention and evaluation of the proposed outcomes.
Feasibility outcomes
- Number of eligible patients
- Assessment of screening and recruitment methods
- The willingness of clinicians to allow recruitment
- The willingness of participants to be randomised
- Assessment of the randomisation process
- Staff attitudes and training needs
- Protocol compliance (barriers to the use of NAVA ventilation)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU admissions who are likely to remain intubated and ventilated for greater than 48 hours with a diagnosis of one or a combination of:
- •Left and/or right ventricular heart failure
- •Mild, moderate or severe (Berlin criteria) Acute Respiratory Distress Syndrome (ARDS)
- •All diagnoses must be documented in the medical notes. There must be evidence of a specialist consultant diagnosis, or a non-specialist doctor diagnosis with either objective test results (spirometry, CT, lung biopsy, cardiac echo) and/or prescribed treatment.
排除标准
- •Less than 18 years old or pregnant
- •Inability to conduct protocol (e.g. research staff or NAVA technology unavailable)
- •No personal or nominated consultee available or assent declined
- •Greater than 96 hours from intubation
- •Greater than 24 hours in the weaning phase
- •Patient likely to die/have treatment withdrawal within 48 hours
- •Contraindication to passing NG tube
- •Patients with primary neurological cause of ventilator dependence
- •High spinal injury above C6; severe traumatic brain injury (Glasgow Coma Score < 8)
- •Suspected or proven hypoxic brain injury
- •Physician refusal / physician wishes to use NAVA
- •Hepatic encephalopathy greater than grade one
- •Domiciliary ventilation (except CPAP/BIPAP used for sleep disordered breathing)
- •Enrollment in another interventional clinical trial in the last 30 days
- •Non-English speakers where inadequate translation available to allow informed consent
研究组 & 干预措施
NAVA technology
Following randomisation, a NAVA catheter will be introduced. The Electrical Activity of the Diaphragm (EAdi) will be viewed primarily to ensure a minimum level of diaphragm activation during the weaning phase. NAVA mode suitability/safety assessments will be conducted in all patients prior to the first initiation of the NAVA mode. The NAVA preview function on the Maquet Servo-i ventilators will be used to transfer from the previous mode to the NAVA mode, and the assessment will last for a maximum of 30 minutes. We are recommending the use of the NAVA ventilation mode during the weaning period. Following the commencement of weaning, sedation holds and spontaneous breathing trials will be conducted according to local protocols.
干预措施: NAVA Technology (Other)
Standard Care
A NAVA catheter will be inserted following randomisation. The NAVA capabilities of the ventilator will be disabled. Patients will be ventilated according to local weaning protocol as per current standard care with either Pressure Support, Synchronised Intermittent Mandatory Ventilation, Volume Controlled Ventilation, Pressure Controlled Ventilation or Pressure Regulated Volume Controlled Ventilation. Following the commencement of weaning, sedation holds and spontaneous breathing trials will be conducted according to local protocols.
结局指标
主要结局
Protocol compliance
时间窗: 28 days
Total time in the NAVA ventilation mode as a proportion of total time in an assisted spontaneous weaning ventilation mode within 28 days from randomisation.
次要结局
未报告次要终点