Overview

A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill (iCOOL 1)

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling associated cerebrovascular disease. The narrow-time-frame is a major issue ("time is brain"). To provide immediate cooling without delay, easy to use, mobile and effective methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. The RhinoChill (BeneChill, USA) is a new device. A comparison of these two induction methods has never been done before. Neither was the effect of cold infusions on brain-temperature measured. For the first time iCOOL 1 compares feasibility, safety and efficacy of the two methods.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital Heidelberg
Treatments:
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- Sedation, intubation and mechanical ventilation

- Combined ICP-temperature-probe

- Indication to lower body temperature

- Age ≥ 18 years

Exclusion Criteria:

- Body weight > 120 kg

- Fever > 38.5°C

- Chronic sinusitis

- Current or past fracture or surgery of the paranasal sinuses

- Severe infection with bacteremia or sepsis ≤ 72 h

- Severe renal insufficiency

- Severe liver insufficiency

- Acute pulmonary embolism

- Acute myocardial infarction

- Severe cardiac insufficiency (NYHA ≥ III)

- Threatening ventricular dysrhythmia

- Cardiac dysrhythmia with bradycardia (heart rate < 50 /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)