Remote Controlled CT Scanning for Decentralized Diagnostics and Treatment Versus Standard Care in Acute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Time from EMC notification to initiation IVT treatment
研究概览
简要总结
The DIRECT-CT trial is designed to test the hypothesis that remote controlled CT scanning combined with real time audio-and video conference (AVC) guided assessment from an experienced hospital stroke team (tele-stroke) at decentralized medical centers (DMC) reduces time to intravenous thrombolytic treatment compared to the standard pathway.
详细描述
Intravenous thrombolysis (IVT) treatment is an effective treatment of disabling acute ischemic stroke (AIS) and leads to improved functional outcomes if administered within 4.5 hours after symptom onset. Since the treatment effect is highly time dependent, it is recommended to give IVT as soon as possible after symptom onset to patients with AIS without contraindications. A CT examination of the head must be performed prior to IVT to exclude intracranial hemorrhage. If an intracerebral hemorrhage (ICH) is detected rapid blood pressure lowering medication should be initiated. As of today, timely delivery of acute stroke treatment is challenging in several parts of Norway due to sparsely populated areas with long geographical distances between hospitals. Patients living in rural areas are at risk of not receiving timely acute stroke treatment. Due to the time sensitive nature of IVT, a decentralized approach to diagnostics and treatment is compelling. However, a CT scanner and medical expertise on acute stroke diagnostics and treatment is not readily available in pre-hospital settings in Norway. Investigators therefore plan to 1) assess the feasibility of widespread implementation of a model with decentralized stroke diagnostics and treatment in rural areas with a stationary CT combined with audio-and video guided support from an experienced stroke team at the local hospital 2) compare treatment access, time metrics and outcomes for stroke patients in the DMC catchment area to patients from similar rural areas without access to decentralized diagnostics and treatment. The risk for patients is minimized through remote controlled CT scanning administered from the local hospital combined with tele-stroke guided assessment by an experienced stroke team and regular simulation trainings. All treatment, including thrombolytic therapy, and monitoring routines are performed according to the hospitals' standard operating procedures (SOP). The primary objective is to compare time from Emergency Medical Communication (EMC) notification to IVT treatment between AIS patients in the intervention group comprising patients from geographical areas with an established service of prehospital stroke diagnostics and treatment at the DMC to the control group comprising patients from similar geographical areas undergoing diagnostics and treatment at their local hospital as per standard pathway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •- Patients in the catchments areas of the intervention and control group presenting with a clinical suspected diagnosis of stroke within symptom onset within the last 24 hours
排除标准
- •- Patients presenting with a clinical suspected diagnosis of stroke more than 24 hours after symptom onset
研究组 & 干预措施
Intervention arm
Participants are patients presenting with acute stroke symptoms in rural districts in Norway. A cockpit solution by Syngo Virtual Cockpit® software for remote control of the stationary CT machine at the DMCs from the nearest stroke center is implemented. The EMC center routes the ambulance to DMC Midt-Troms when it is the nearest. A nurse at DMC and the ambulance personnel performs the clinical examination and positions the patient in the CT machine. Through AVC the examination is overseen by the stroke physician, images are interpreted by a radiologist at UNN, and the decision regarding acute treatment is made by the stroke physician at UNN, Tromsø. If indicated, IVT and blood pressure lowering medication is administered by the nurse at the DMC. Patients resenting with acute stroke symptoms in the catchment area of DMC Midt-Troms (Sørreisa and Senja municipalities) and DMC Sør-Helgeland (Brønnøy and Sømna municipalities) comprise the intervention group.
干预措施: Decentralized diagnostics and treatment (Other)
Control
1) Patients presenting with acute stroke symptoms residing in municipalities in Nord-Troms (Nordreisa, Kåfjord, Skjervøy and Kvænangen) and Nordland (Saltdal, Hamarøy, Steigen and Sørfold) from the time of DMC model implementation until end of study. These patients are from areas that are geographically similar to Midt-Troms and Sør-Helgeland with regards to distance to the nearest hospital, but without access to prehospital CT diagnostics and acute stroke treatment.
Historical control
This control group consists of acute stroke patients from the same municipalities (both intervention and control group) presenting with stroke symptoms within a 5 year period prior to the implementation of prehospital diagnostics and treatment at the DMC.
结局指标
主要结局
Time from EMC notification to initiation IVT treatment
时间窗: Day 0
The time from Emergency Medical Communication notification to initiation intravenous thrombolysis treatment in eligible patients
次要结局
- Time from admittance to initiation of IVT treatment (door-to-needle time)(Day 0)
- Time from admittance to start of blood pressure lowering medication in ICH patients(Day 0)
- Proportion of AIS patients receiving IVT treatment (y/n)(Day 0)
- Proportion of AIS patients receiving EVT treatment (y/n)(Day 0)
- Proportion of patients achieving early neurological improvement(Day 1)
- mRS score at 90 days(Month 3)
- Proportion of patients with symptomatic intracranial hemorrhage (sICH)(Day 1)
- Time from symptom onset to groin puncture time(Day 0)
- Transportation mode (ground or air ambulance)(Day 0)
- Mortality(Year 1)
- Final diagnosis(Week 2)