CT-Perfusion for Neurological Diagnostic Evaluation
Palabras clave
Abstracto
Descripción
The investigators will conduct a large prospective Canadian multi-centre diagnostic cohort study. The primary diagnostic test evaluated will be CT-perfusion. The reference standard will be the complete clinical evaluation of brainstem functions. Comatose patients at high risk of neurological death exempt of confounding factors (e.g. hypothermic patients, use of long-acting sedatives, etc.) will be included. All patients will undergo CT-perfusion of the head (with CT-angiography reconstructions) followed by a complete NDD assessment. Both CT-perfusion and the clinical exam will be performed by independent assessors blinded from each others' interpretation. The primary endpoints will be the sensitivity and specificity of CT-perfusion to confirm NDD. Safety endpoints will be CT-perfusion -related adverse events (i.e. contrast-induced kidney injury, new hemodynamic instability while undergoing CT-perfusion). The true negative, true positive, false negative and false positive for CT-angiography obtained from the CT-perfusion source images when compared to the reference standard as well as when compared to the CT-Perfusion will also be reported. The sensitivity and specificity of CT-angiography compared to the reference standard and to CT-perfusion along with corresponding 95% confidence intervals will be calculated. Individual patient and population pharmacokinetics of analgesics and sedatives will be determined. To better investigate the impact of residual circulating sedative or narcotic levels on the accuracy of CT-Perfusion and CT-Angiography, Receiver Operating Characteristics (ROC) curves for varying levels of narcotic or sedative thresholds and compute the ROC area under the curve for each threshold will be plotted. To assess the immune phenotype, peripheral blood mononuclear cells activation will be evaluated by flow cytometry and cytokines by multiplex analyses. Nanovesicles fraction will be isolated from the plasma by ultracentrifugation and antigenic content and enzymatic activity. The plasma will finally be analysed by ELISAs and multiplex analyses to determine the levels of pro-inflammatory cytokines.
fechas
| Verificado por última vez: | 09/30/2019 |
| Primero enviado: | 03/21/2017 |
| Inscripción estimada enviada: | 03/26/2017 |
| Publicado por primera vez: | 03/30/2017 |
| Última actualización enviada: | 07/16/2020 |
| Última actualización publicada: | 07/19/2020 |
| Fecha de inicio real del estudio: | 04/24/2017 |
| Fecha estimada de finalización primaria: | 03/30/2021 |
| Fecha estimada de finalización del estudio: | 03/30/2021 |
Condición o enfermedad
Intervención / tratamiento
Diagnostic Test: Neurological Diagnostic Evaluation
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Other: Neurological Diagnostic Evaluation Exams performed according to a determined schedule following admission in the intensive care unit in order to validate CT-perfusion as an accurate ancillary test for neurological diagnostic. | Diagnostic Test: Neurological Diagnostic Evaluation Clinical Data:
Demographic data
Daily data (clinical exams, laboratory data)
Drug administration
Additional clinical or ancillary neurological determination test
Diagnostic Intervention:
CT-Perfusion
CT-Angiography reconstructions
Reference Standard:
- Clinical Neurological Exam
Blood Samples (Pharmacokinetics, Inflammatory & Nanovesicles Parameters):
At the time of patient enrolment
6 hours after patient enrolment
At the time of the clinical neurological exam
Secondary Outcome measures at 6 months:
extended Glasgow Outcome Scale (GOSe)
modified Rankin Scale (mRS) |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: 1. Adults 18 years and older 2. Admitted in the intensive care unit with a brain injury 3. Glasgow Coma Scale (GCS) = 3 4. Sedation stopped for at least 6 hours Exclusion Criteria: 1. Patients with the following contraindications to CT-perfusion will be excluded from the study: - Pregnancy - Contrast allergy - Clinician refuses inclusion because of kidney injury. 2. Patients with any of the following confounding factors precluding complete clinical neurological evaluation will be excluded from the study: - Cervical fracture above C6 - Significant facial trauma limiting cranial nerve examination - Hypothermia < 34 °C - Use of intravenous barbiturates at any time since admission - Unresuscitated shock - Peripheral nerve or muscle dysfunction or neuromuscular blockade potentially accounting for unresponsiveness - Anoxic brain injury < 24h (or 72h if therapeutic hypothermia) - Attending physician disagrees to conduct an apnea test - Any other abnormalities deemed a confounding factor for NDD by the attending clinician |
Salir
Medidas de resultado primarias
1. Accuracy of CT-perfusion [CT-Perfusion scan and clinical assessment must be less than 2 hours apart]
Medidas de resultado secundarias
1. Predictive Values [CT-Perfusion scan and clinical assessment must be less than 2 hours apart]
2. Likelihood Ratios [CT-Perfusion scan and clinical assessment must be less than 2 hours apart]
3. Inter-rater Agreement [CT-Perfusion scan and clinical assessment must be less than 2 hours apart]
4. Volume of Distribution [48 hours]
5. Clearance [48 hours]
6. Elimination Rate Constant [48 hours]
7. Concentration-time Curve [48 hours]
8. Accuracy of CT-perfusion at 6 Months [6 months]
9. Accuracy of the Predictive Values at 6 Months [6 months]
10. Accuracy of the Likelihood Ratios at 6 Months [6 months]
11. Accuracy of the Inter-rater Agreement at 6 Months [6 months]
