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The Norwegian Acute Stroke Prehospital Project (NASPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03036020
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Kristi G. Bache, PhD, Norwegian Air Ambulance Foundation

Brief Summary:

The main aim of the NASPP study is to assess the efficacy and safety of the prehospital diagnosis of stroke using the Norwegian stroke ambulance concept. NASPP aims to demonstrate that anesthesiologists trained in pre-hospital critical care may perform acute stroke diagnostics by clinical assessment and CT scan interpretation and integrating these skills in the already existing organizational frame of the Norwegian prehospital EMS system.

NASPP will systematically explore the Norwegian model of prehospital acute stroke diagnostics prior to the implementation of prehospital thrombolytic stroke treatment. NASSP will equip a regular ambulance staffed with a specially trained anesthesiologist and a specialized nurse. NASPP will perform the clinical part of the study in close co-operation with Østfold Hospital, Fredrikstad.


Condition or disease Intervention/treatment Phase
Acute Stroke Traumatic Brain Injury Radiation: CereTom Neurologica Samsung Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Norwegian Acute Stroke Prehospital Project
Study Start Date : October 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Experimental: Contraindication anesthesiologists
Ability of anesthesiologists to detect contraindications to thrombolysis in acute stroke patients prehospital by interpretation of prehospital cerebral CT scans
Radiation: CereTom Neurologica Samsung
Diagnosis of acute stroke patients by cerebral CT diagnostics prehospital




Primary Outcome Measures :
  1. Inter-rated agreement between the anesthesiologist and the inhospital stroke team (radiologist and neurologist) [ Time Frame: Baseline ]
    The ambulance anesthesiologist assesses the pre-hospital cerebral CT scan and fills out the predefined variables in designated study forms. All cerebral CT interpreations are categorized in 1) no radiological contraindication to thrombolytics 2) yes radiological contraindication to thrombolytics. The CT scan is simultaneously sent to the hospital, for interpretation by the neurologist and the radiologist on call. The anesthesiologist intgerpration is blinded to the stroke team. A neuroradiologist will, without any clinical knowledge, review the CT scans after the study has included is completed. The results from the initial interpretation by the ambulance anesthesiologist are held anonymous, and blinded for the neuroradiologist. The results will be analyzed statistically to show distribution of the different categories of inter-rater agreement, compared to the neurologists and radiologists at the admission hospital.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients met by emergency services within 4 hours after symptom onset
  • Stroke symptoms: sudden weakness of leg or arm, especially on one side, facial asymmetry and/or sudden trouble walking, and speech disturbance (Norwegian Index of medical emergencies 27.03-27.05).
  • Patients from the Hospital dispatch center area, being more than 10-15 minutes drive from the hospital.
  • Giving informed consent, written or oral, if possible or consent from relative at site

Exclusion Criteria:

  • Age under 18 years
  • Pregnancy
  • Female < 50 years and uncertainty of pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036020


Locations
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Norway
Østfold Hospital Norway
Fredrikstad, Norway
Sponsors and Collaborators
Kristi G. Bache, PhD
Oslo University Hospital
Investigators
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Principal Investigator: Christian G Lund, MD Phd Oslo University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kristi G. Bache, PhD, Head of Research Department at The Norwegian Air Ambulance Foundation, Norwegian Air Ambulance Foundation
ClinicalTrials.gov Identifier: NCT03036020     History of Changes
Other Study ID Numbers: NASPP-2
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stroke
Brain Injuries
Brain Injuries, Traumatic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries