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ID
Source
Brief title
Health condition
Ischaemic stroke, Intra-arterial thrombectomy, Near infrared spectroscopy
Ischemische beroerte, intra-arteriële trombectomie, bijna infrarode spectroscopie
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Periprocedural cerebral oxygenation of the ischemic and non-ischemic hemisphere; specifically:
- Before and after the induction of anaesthesia
- Before and after the thrombectomy (reperfusion)
- Before and after the end of anaesthesia
2. Neurological outcome quantified by:
- NIHHS score
Secondary outcome
1. Demographic parameters
2. Radiological imaging:
- Location of the vascular occlusion and the level of collateral vasculature
- Modified Thrombolysis In Cerebral Infarction (mTICI)-score after thrombectomy
- Physiological and pharmacological variables before, during and after the procedure
- Physiological variables: Heart rate, invasive blood pressure, non-invasive blood pressure, FiO2, CO2, arterial haemoglobin saturation, EEG measure (if used)
- Pharmacological variables: drugs used, doses and concentrations administered
Background summary
Intra-arterial thrombectomy (IAT) is a well-proven method of restoring cerebral perfusion in patients suffering from an ischemic stroke. Anesthetic patient management during the IAT, on the other hand, is not evidence based. The existing guidelines are based on expert opinion and advise only broadly on periprocedural blood pressure management without accounting for any specific patient and procedural factors.
In brain tissue areas, where perfusion is critically low, functioning of the brain autoregulation mechanism is extremely challenged. Any further drops perfusion may lead to hypo-perfusion and irreversible ischemia while sudden increase in perfusion pressure, like after recanalization, can lead to hyper-perfusion and potentially to haemorrhagic conversion. Thus, there is a need for a measure of cerebral perfusion to guide and individualize the blood pressure management. Near infrared spectroscopy (NIRS) might provide the answer.
Study objective
The NIRS monitor is capable of detecting changes in cerebral oxygenation
Study design
NIRS: continous collection of data througout the surgery
NIHHS: pre-procedure, after 24 hrs, at discharge
Modified Rankin scale: after 3 months
Intervention
Before the IAT, a NIRS sensor will be applied to the skull, bilaterally, directly above the flow region of the middle cerebral artery (MCA).
ADDENDUM (06-07-2019):
On arrival in the angiography suite, the NIRS sensors will be applied to the scalp bilaterally. When eligible patients or their legal representatives are able to provide informed consent, NIRS sensors will be applied over the temporal lobes. If informed consent cannot be acquired before the start of the procedure, for example due to patient aphasia and/or absence of legal representatives, the NIRS sensors will be applied over the frontal lobes. Deferred consent will be sought and attained at a later date before the use of the data from these patients.
Inclusion criteria
- Equal or above 18 years of age
- An ischemic stroke caused by a proximal arterial occlusion of the MCA
- Eligible to undergo IAT under general anaesthesia
Exclusion criteria
- Consent is not given by patient or his/her legal representative.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7323 |
| NTR-old | NTR7539 |
| Other | UMCG Research Register number : 201800631 |