Carbon-Dioxide Flushing Versus Saline Flushing in Thoracic Endovascular Aortic Repair to Reduce Neurological Injury: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Study design for full randomised controlled trial
研究概览
简要总结
Vascular brain infarction (VBI) occurs in 67% of patients undergoing TEVAR. Overt stroke occurs in 13% of these patients and 88% of patients suffer from neurocognitive impairment.
Cerebral air embolisation during the stent-graft deployment phase of TEVAR may be a cause of VBI. Standard treatment to de-air stent-grafts is through the use of a saline flush.
This study aims to investigate whether carbon-dioxide or saline is the better fluid to de-air TEVAR stent-grafts prior to insertion in to the patient and compare VBI rate in the carbon-dioxide group and saline group.
详细描述
Thoracic endovascular aortic repair (TEVAR) is the re-lining of the thoracic aorta to prevent life threatening haemorrhage and death from rupture. This involves a small cut in the femoral artery in the groin and under imaging guidance, the insertion of wires and a stent into the thoracic aorta.
Prior to insertion into the patient, stents are flushed with saline to remove air and prevent air reaching the brain that can cause a form of brain injury known as vascular brain infarction (VBI). However, our preliminary clinical data suggests that saline flushing is not effective at de-airing stent-grafts used in TEVAR.
Carbon-dioxide has been used extensively in cardiac surgery to displace air from the chest cavity to prevent peri-procedural cerebral air embolisation. We hypothesise that flushing the stent-grafts with carbon-dioxide may be better at removing air from the stent-grafts than saline flush.
Patients undergoing TEVAR will be approached to participate in this study. After written consent is obtained, participants will be randomised to undergo (TEVAR) with carbon dioxide or saline flushing of stent-grafts. Pre-operatively, participants will undergo extensive neurocognitive testing, and a baseline blood test. Intra-operatively, participants will undergo continuous transcranial doppler monitoring (TCD) of the middle cerebral artery (MCA) to look for cerebral air embolisation at stent-graft deployment phase of TEVAR. Blood testing pre-op, immediately post op, and 24 hours post op will be taken to measure for biomarkers of brain injury. Post-operatively, participants will undergo another diffusion-weighted brain MRI within 72 hours post-procedure, stroke and delirium assessment at day 1, 3 and day 7 +/- day of discharge, and at 6-weeks and 6-month follow-up.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to treatment allocation. Assessment of TCD embolic data, DW-MRI scan reporting and neurological and neurocognitive assessment will be carried out by blinded trained assessors.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants suitable for TEVAR with capacity to consent
排除标准
- •Participants who lack capacity to consent
- •Contraindications to MRI such as pacemaker
- •Pregnant participants
- •Participants who do not wish to participate
- •Participants <18yrs
结局指标
主要结局
Study design for full randomised controlled trial
时间窗: 36 months
The proportion of patients who are eligible for the trial will be collected
Retention
时间窗: 36 months
The proportion of patients undergoing follow-up assessments will be collected
Recruitment
时间窗: 36 months
The number of patients recruited into the trial will be collected
次要结局
- Number of gaseous and solid intra-operative transcranial doppler microembolic signals by phase of TEVAR(Duration of surgery, 36 months collection)
- Serial biomarker blood tests(36 months)
- Risk factor assessment(36 months)
- Number of participants with stroke or delirium as an inpatient(These will be carried out within 48 hours of patients' return to level 1 care. 36 months collection)
- Neurological assessment, delirium assessment and quality of life testing(Pre-op, first outpatient assessment (approximately 6 weeks), 6 months. 36 months collection)
- Number, size and location of new ischaemic lesions on post-operative diffusion-weighted MRI scans(36 months)
