Intervention With Cerebral Embolic Protection in TEVAR: Gaseous Protection
Түлхүүр үгс
Хураангуй
Тодорхойлолт
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 a diffusion-weighted MRI brain scan, full neurological examination and neurocognitive testing. 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. Post-operatively, particpants will undergo another diffusion-weighted brain MRI within 72 hours post-procedure, neurological examination for the first 7 days, and neurocognitive tests prior to discharge, and at 6-weeks and 6-month follow-up.
Огноо
| Сүүлд баталгаажуулсан: | 04/30/2019 |
| Эхлээд оруулсан: | 03/19/2019 |
| Тооцоолсон элсэлтийг оруулсан: | 03/20/2019 |
| Эхлээд нийтэлсэн: | 03/21/2019 |
| Сүүлийн шинэчлэлтийг оруулсан: | 05/07/2019 |
| Сүүлийн шинэчлэлтийг нийтэлсэн: | 05/08/2019 |
| Сургалтын бодит эхлэх огноо: | 07/31/2019 |
| Тооцоолсон анхан шатны ажил дуусах огноо: | 03/31/2021 |
| Судалгааны ажлыг дуусгах өдөр: | 09/30/2021 |
Нөхцөл байдал эсвэл өвчин
Хөндлөнгийн оролцоо / эмчилгээ
Other: carbon-dioxide
Other: Saline
Үе шат
Arm Groups
| Гар | Хөндлөнгийн оролцоо / эмчилгээ |
|---|---|
| Experimental: carbon-dioxide Flushing of stent-grafts in TEVAR with carbon-dioxide | Other: carbon-dioxide As above |
| Active Comparator: Saline Flushing of stent-grafts with saline | Other: Saline As above |
Эрхийн шалгуур
| Суралцах боломжтой нас | 18 Years Хэнд 18 Years |
| Суралцах боломжтой хүйс | All |
| Эрүүл сайн дурын ажилтнуудыг хүлээн авдаг | Тийм ээ |
| Шалгуур үзүүлэлтүүд | Inclusion Criteria: - All participants suitable for TEVAR with capacity to consent Exclusion Criteria: - Participants who lack capacity to consent - Contraindications to MRI such as pacemaker - Pregnant participants - Participants who do not wish to participate - Participants <18yrs |
Үр дүн
Анхан шатны үр дүнгийн арга хэмжээ
1. Number of participants with new diffusion-weighted MRI brain scan [Within 72hrs]
Хоёрдогч үр дүнгийн арга хэмжээ
1. Number, size and location of new ischaemic lesions on post-operative diffusion-weighted MRI scans [Within 72hrs]
2. Number of gaseous and solid intra-operative transcranial doppler microembolic signals by phase of TEVAR [Duration of surgery]
3. Stroke rate [1-7 days within hospital, 6-weeks post-operatively and 6-months post-operatively.]
4. Number of participants with neurocognitive impairment from baseline [3-7 days post-operatively, 6-weeks post-operatively and 6-months post-operatively.]
