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Table 1 Inclusion/exclusion criteria

From: Rapid Induction of COOLing in Stroke Patients (iCOOL1): a randomised pilot study comparing cold infusions with nasopharyngeal cooling

Inclusion criteria:

Exclusion criteria:

â—‹ Ischaemic or haemorrhagic stroke

○ Severe cardiac insufficiency (NYHA ≥ III)

â—‹ ICP/temperature brain probe

â—‹ Acute myocardial infarction or pulmonary embolism

â—‹ Indication for therapeutic cooling independent of the study

○ Threatened ventricular dysrhythmia or cardiac dysrhythmia (heart rate <50/min, QTc >450 ms, sick sinus syndrome, AV block II-III°)

â—‹ Sedation, intubation, and mechanical ventilation

â—‹ Chronic sinusitis or current or past fracture or surgery of the paranasal sinuses not allowing secure application of nasopharyngeal cooling

○ Age ≥18 years

○ Severe infection with bacteraemia or sepsis ≥72 h

â—‹ Written informed consent by patient or legal representative

○ Fever >38.5°C

 

â—‹ Severe renal or liver insufficiency

 

â—‹ Known haematologic disease with increased risk of thrombosis (e.g., cryoglobulinaemia, cold agglutinins or sickle cell anaemia)

 

â—‹ Known vasospastic vascular disorder (e.g., Raynaud phenomenon or thromboangiitis obliterans)

 

â—‹ Body weight >120 kg