Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01584167
Eligibility Criteria:
Inclusion Criteria:
* Sedation
* Combined ICP-temperature-probe
* Indication to lower body temperature \> 1.5°C
* Age ≥ 18 years
Exclusion Criteria:
* Body weight \> 120 kg
* Severe renal insufficiency
* Acute pulmonary embolism
* Acute myocardial infarction
* High-grade heart valve stenosis or insufficiency
* Severe cardiac insufficiency (NYHA ≥ III)
* Threatening ventricular dysrhythmia
* Cardiac dysrhythmia with bradycardia (heart rate \< 45 /min, QTc \> 450 ms, sick sinus syndrome, AV-block II-III°).
* Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
* Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
* Skin lesions not allowing a secure application of the EMCOOLS Flex.Pads
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01584167
Study Brief:
Protocol Section:
NCT01584167