Vasospasm Intracranial
Conditions
Keywords
SAH, Hypercapnia, DCI
Brief summary
Temporary hypercapnia leads to a reproducible increase of cerebral blood flow (CBF) and brain tissue oxygenation (StiO2) as shown in a previous study (Trial-Identification: NCT01799525). The aim of this study now was to measure the course of carbon dioxide partial pressure (pCO2) reactivity after prolonged hypercapnia, and to evaluate the therapeutic effect of graded hypercapnia.
Detailed description
Cerebral vasospasm still is the leading cause of delayed cerebral ischemia (DCI) and secondary ischemic deficits after aneurysmal subarachnoid hemorrhage (SAH). Hypercapnia leads to a reproducible increase of cerebral blood flow (CBF) and brain tissue oxygenation (StiO2) as shown in a previous study (Trial-Identification: NCT01799525). Furthermore, the increase of CBF and StiO2 sustained after normalization of ventilation and no rebound effect was found. So, a possible optimization of the hypercapnic period may lead to prolonged effects of increased CBF and StiO2. Aim of this stuy is to find the ideal duration of hypercapnia and to evaluate the therapeutic effect of graded hypercapnia. For this, intubated and mechanically ventilated patients with an aneurysmal SAH Hunt/Hess 3-5, Fisher grade 2-4 on the initial CT scan and supplied with an external ventricular drainage will be included within the first 96 hours after ictus. Between day 4 and 14 they undergo a trial intervention in which the respiratory minute volume will be reduced in order to maintain a target PaCO2 of 50 - 55 mmHg for 2 hours. Arterial blood gas analysis (ABG) and transcranial Doppler sonography (TCD) is performed in 15-minute intervals. Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and cardiovascular parameters are monitored continuously, serial measurement of CBF and StiO2 under continous hypercapnia is performed. Primary endpoint of this trial is change of CBF under hypercapnia, secondary endpoints are StiO2, measures non-invasively with near-infrared spectroscopy, mean flow velocity of intracranial vessels in TCD, delayed cerebral infarction in cranial CT and Glasgow Outcome Score (GOS) after 6 months.
Interventions
PROCEDURETemporary hypercapnia
Temporary daily hypercapnia for 2 hours between day 4 and 14 after SAH
Sponsors
University of Wuerzburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aneurysmal SAH * Aneurysm occluded by clipping/coiling within 96 hours * Hunt/Hess 3-5 * Fisher 2-4 on initial CT scan * Intubated, sedated and mechanically ventilated patient * Continous drainage of cerebrospinal fluid (CSF)
Exclusion criteria
* Age under 18 years * Pregnancy * Common obstructive lung disease (COLD) * potential of hydrogen (pH) in ABG \< 7,25 * ICP \> 20 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral blood flow (CBF) | 2-4 hours, day 4-14 after SAH | Changes of CBF (absolute, ml/100g tissue/min) under changes of arterial pCO2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral tissue oxygen saturation | 2-4 hours, day 4-14 after SAH | Changes of tissue oxygen saturation measured by near-infrared spectroscopy (NIRS) |
| Glasgow Outcome Score (GOS) | up to 6 months | Glasgow Outcome Score (GOS 1 - 5, GOS 1 = Death, GOS 5 = none or low disability) after 14 days, after discharge and 6 months |
Outcome results
None listed