Prehospital Resuscitation Intranasal Cooling Effects Seen in MRI of the Brain After Cardiac Arrest

NCT02179060 | Terminated

• 1 other identifier: R14025
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Therapeutic hypothermia improves the neurologically-intact survival rates in those patients resuscitated out-of-hospital from ventricular fibrillation. Cooling as early as possible might be beneficial to those victims. Diffusion Tensor Imaging and diffusion-weighted magnetic resonance imaging have recently shown to be able to identify early ischemia-related changes within the brain three days after cardiac arrest, among sudden cardiac arrest patients cooled in hospital. The physical changes seen within the brain may be able to distinguish survivors at very early phase. This study aims to assess early ischemia-related changes of the brain seen in MRI approximately three days after cardiac arrest. The hypotheses is that MRI will differ in the groups of patients treated with early intra-arrest cooling with the RhinoChill device and in hospital hypothermia in 36 Celsius, in the group of patients treated with normal in hospital hypothermia in 36 Celsius only, in the group of patients treated with normal in hospital hypothermia in 33 Celsius only (The historical Xenon study patients). The primary endpoint is the presence and pattern of white matter and gray matter degeneration and volumetric changes of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI, and secondary endpoints are total survival at 90 days, and time to reach a target temperature (≤36/33 Celsius).

Conditions

Cardiac Arrest

Keywords

Sudden cardiac arrest, RhinoChill -cooling, MRI

Outcome Measures

Primary Outcomes (1)

• the presence and pattern of white matter and gray matter degeneration and volumetric changes of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI

  36-49 hours after cardiac arrest

Secondary Outcomes (1)

• the total survival at 90 days

  90 days after cardiac arrest

Other Outcomes (1)

• time to reach a target temperature (≤36/33 Celsius)

  0-12hours after cardiac arrest

Study Arms (2)

Cooling group

The RhinoChill® cooling is started as soon as possible to the patients with Cardiac arrest, and before the return of spontaneous circulation

Control group

Standard care, no cooling during pre-hospital care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects will be derived from the prehospital cardiac arrest patients from Tampere area treated by the Tampere Area Emergency Medical Service (EMS) led by physician. The study population (N=10) is from Pirkanmaa area. The paramedics are allowed to start intra-arrest cooling by RhinoChill whenever they meet an adult SCA patient in VF/VT. The third group of control subjects are same as used in "Effect of Xenon, in Combination with Therapeutic Hypothermia, on the Brain and on Neurological Outcome following Brain Ischemia in Cardiac Arrest Patients (EudraCT number 2009-009505-25)" -study running in Turku and Helsinki, Finland. They are the prehospital cardiac arrest patients from Turku and Helsinki area treated by the Turku or Helsinki Area Emergency Medical Service.

You may qualify if:

• Ventricular fibrillation or non-perfusive ventricular tachycardia as initial cardiac rhythm.
• The 1st attempt at resuscitation by emergency medical personnel must appear within 15 minutes after the collapse.
• The cause for collapse should be considered primary as cardiogenic and the return of spontaneous circulation (ROSC) should have been gained in 45 minutes after the collapse.
• Patient should be still unconscious in the emergency room.
• Age: 18 - 80 years
• Obtained consent after arrival to the hospital, and before MRI scan.

You may not qualify if:

• Hypothermia (\< 30°C core temperature)
• Arrival of EMS after 15 minutes from collapse
• Unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral haemorrhages, intoxications etc.)
• Terminal phase of a chronic disease, or known limitations in therapy and Do Not Resuscitate-order or known pre-arrest Cerebral Performance Category 3 or 4
• Factors making participation in follow-up unlikely
• Factors making the RhinoChill cooling contraindicated: patients with known contraindications to hypothermia (Raynaud's disease, Cryoglobulinemia, Sickle Cell disease), have specific temperature-sensitive pathologies (e.g., serum cold agglutinins, Buerger's disease), intranasal obstruction, or known skull base fracture.
• Pregnancy
• Coagulopathy
• Response to verbal commands after the return of spontaneous circulation (ROSC)
• Systolic arterial pressure \< 80 mmHg or mean arterial pressure \< 60 mmHg for over 30 min period after ROSC
• Evidence of hypoxemia (arterial oxygen saturation \< 85%) for \> 15 minutes after ROSC

Sponsors & Collaborators

• Tampere University Hospital: lead
• Turku University Hospital: collaborator
• Helsinki University Central Hospital: collaborator
• BeneChill, Inc: collaborator

Study Sites (1)

Tampere University hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Heart Arrest; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sanna Hoppu, MD, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: July 1, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

FI (1)