Cerebral Aneurysm, Pupillary Function, Abnormal
Conditions
Keywords
pupillometry, autonomous nerve system
Brief summary
The pupilometer determines the alteration of the pupil diameter after a defined light stimulus. In this study data is collected from pupilometer measurements of patients with an acute cerebral disease. The measurements take place during daily neurological routine examinations. The values are compared to outcomes resulting from pupilometer measurements done on patients having not an acute cerebral disease (e.g. cerebral aneurysm without symptoms). The study aims to establish the not invasive method of pupillometry for detecting neurological degradations early.
Detailed description
The pupilometer determines the alteration of the pupil diameter after a defined light stimulus providing information of the autonomic nerve system. The result collecting from pupillometry is objective and more precise than the subjective-visual evaluation of the pupil and its reactivity. In this observational study data is collected from pupilometer measurements of patients with an acute cerebral disease. The measurements take place during neurological routine examinations. The first measurement is done during the initial diagnosing examination, followed by daily measurements and ending with measurements after 3 and 6 month upon hospital discharge. The values are compared to standard values resulting from pupilometer measurements done on patients having non-acute cerebral disease (e.g. cerebral aneurysm without symptoms). The study aims to establish the not invasive method of pupillometry for detecting neurological degradations early.
Interventions
DEVICEPupilometer
Device to measure change in pupil diameter due to a defined light stimulus.
Sponsors
RWTH Aachen University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female patient, age ≥ 18 years * signed consent * treatment group: * patient with acute, cerebral disease verified by CT, MRI or spinal tap * control group * patient with non-acute cerebral disease like a new diagnosed aneurysm without symptoms
Exclusion criteria
* female or male patient aged \< 18 years * absent of signed consent * persons who have a dependent or working relationship with the sponsor or investigator * persons who are sheltered in an institution by juridical or governmental order * concurrent participation in an other clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of delayed cerebral ischemia (DCI) | 21 days | DCI is defined as the development of new focal neurological signs and/or deterioration in level of consciousness, lasting for more than 1 h, or the appearance of new infarctions on CT or MRI. |
| Number of perfusion deficiency | 21 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transcranial Doppler (TCD) -fluency increase [cm/s] | 21 days | \> 150 cm/s absolute or increase \> 50 cm/s within 24 h |
| Digital subtraction angiography (DSA) | day 7 ± 2 d | Detection of an angiographic vasospasm |
| Glasgow Outcome Score (GOS) | after 3 and 6 month | Standardized and objective description of the degree of recovery of patients suffered from a cerebral disease. |
Countries
Germany
Contacts
Primary ContactChristina Kalvelage, M. Sc.
Backup ContactGerrit Alexander Schubert, Prof.
Outcome results
None listed