NCT01573117

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

1.2 years

First QC Date

March 31, 2012

Last Update Submit

April 25, 2012

Conditions

Ischemic StrokeHemorrhagic Stroke

Keywords

hypothermiainduction of hypothermiacold infusionnasopharyngeal coolingstrokeintracranial hemorrhagecerebrovascular diseaseneuro intensive care

Outcome Measures

Primary Outcomes (1)

  • Brain temperature

    Primary endpoint: Change of brain temperature during one hour after start of cooling. Repeated measurement ANOVA for within subject contrasts (phase 1 (0 to 15min), 2 (15 to 30min), 3 (30 to 45min) and 4 (45 to 60min)) vs. baseline (-15 to 0min)

    -15 to +60min

Secondary Outcomes (3)

  • (Neuro-)vital parameters

    -15 to +60 min

  • Cerebral autoregulation

    -15 to +60 min

  • Safety

    0-6 months

Study Arms (2)

Cold infusions

ACTIVE COMPARATOR

Infusion of 2L cold crystalloid solution (4°C) over 30 minutes

Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution

RhinoChill

ACTIVE COMPARATOR

Nasopharyngeal cooling with the RhinoChill device (BeneChill, USA)

Device: RhinoChill

Interventions

RhinoChillDEVICE

Nasopharyngeal cooling with the RhinoChill device

Also known as: BeneChill, USA
RhinoChill
Cold crystalloid infusions, 0.9%NaCl or Ringer's solutionDRUG

Infusion of 2L cold crystalloid solution (4°C) over 30 minutes

Cold infusions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedation, intubation and mechanical ventilation
  • Combined ICP-temperature-probe
  • Indication to lower body temperature
  • Age ≥ 18 years

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (1)

  • Poli S, Purrucker J, Priglinger M, Ebner M, Sykora M, Diedler J, Bulut C, Popp E, Rupp A, Hametner C. Rapid Induction of COOLing in Stroke Patients (iCOOL1): a randomised pilot study comparing cold infusions with nasopharyngeal cooling. Crit Care. 2014 Oct 27;18(5):582. doi: 10.1186/s13054-014-0582-1.

    PMID: 25346332DERIVED

MeSH Terms

Conditions

Ischemic StrokeHemorrhagic StrokeHypothermiaStrokeIntracranial HemorrhagesCerebrovascular Disorders

Interventions

Sodium ChlorideRinger's Solution

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHemorrhagePathologic Processes

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Sven Poli, Dr. med.

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neurologist, Principal Investigator

Study Record Dates

First Submitted

March 31, 2012

First Posted

April 6, 2012

Study Start

September 1, 2010

Primary Completion

November 1, 2011

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations

DE(1)