High Flow Oxygen Therapy After Spinal Cord Injury - Feasibility Study to Design a Pragmatic Randomised Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Recruitment rates
研究概览
简要总结
The goal of this feasibility study is to learn about the ability to use a different form of oxygen therapy (known as high flow oxygen therapy) in patients who have a spinal cord injury in the upper back or neck.
The main questions it aims to answer are:
- Is it possible to recruit patients to the study
- It is possible to follow the protocol in its current format
- What is the impact on those receiving the intervention.
Participants will be randomised to receive either standard care or high flow oxygen therapy for 10 days following inclusion.
详细描述
In the UK, the annual incidence of acute spinal cord injury (SCI) is 19 new cases per million population, contributing to an estimated 50,000 people who are currently living with SCI1. Trauma is the most common cause of SCI, predominantly from falls and road traffic accidents. Damage to the spinal cord occurs both at the time of injury (primary) and in its aftermath (secondary). Effectively treating and preventing secondary cord injury, and managing complications associated with SCI, can make a significant improvement to patient outcomes.
Respiratory dysfunction is one of the most common medical complications, as well as the leading cause of reduced Quality of Life (QoL) and mortality, with literature indicating that 67% of individuals with a spinal cord injury present with respiratory complications in the acute stage.
The most common respiratory complications are: 1) atelectasis; 2) pneumonia; and 3) respiratory failure. A retrospective review of the patients with acute traumatic spinal cord injuries at C5-T5 level showed a higher prevalence of respiratory complications during the initial hospitalisation just after the injury and suggests the presence of previous respiratory disease, complete motor impairment
(AISA A-B) and coexistent thoracic trauma are a predictor of respiratory complications. Individuals with cervical and higher thoracic spinal cord injuries are more likely to develop respiratory complications, primarily due to diaphragm impairment.
Due to the above, patients have increased rates of infection, poor sputum clearance and inadequate humidification. These complications lead to prolonged admissions, admission to intensive care and considerable healthcare related costs. As such it is essential to develop new management protocols to reduce the occurrence of pulmonary complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Spinal cord injury between C4 and T4 (Include ASIA A-D)
- •Admitted to spinal injury ward within 24-48hours of injury
排除标准
- •Aged under 18 years
- •3 or more rib fractures or flail
- •Sternal fracture
- •Concomitant lung injury
- •Unable to gain informed consent from participant
- •Contra-indication to using high flow therapy e.g., undrained pneumothorax, facial fractures, nasal obstruction, CSF leak, suspected or confirmed base of skull fracture, active epistaxis or recent functional endoscopic sinus surgery.
结局指标
主要结局
Recruitment rates
时间窗: 10 days
This will explore the ability to recruit eligible participants in a timely fashion as per the protocol. It will also capture the participant retainment rates during the study E.g., number of patients recruited, and % of those recruited completing study
次要结局
- Pulmonary complications(10 days)
- Frequency of physiotherapy interventions(10 days)
- To determine the acceptability of the intervention(10 days)
- Physiotherapy time(10 days)
- Incidence of ICU admission(10 days)