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Analgesia in ÖAMTC Helicopter Emergency Service in Austria

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: NCT03760302
Recruitment Status : Active, not recruiting
First Posted : November 30, 2018
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

Tracking Information
First Submitted Date November 26, 2018
First Posted Date November 30, 2018
Last Update Posted Date June 4, 2020
Actual Study Start Date December 1, 2018
Actual Primary Completion Date October 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 29, 2018)
  • Successful analgesia [ Time Frame: 2000-2016 ]
    Change in reported pain severity before and after treatment with analgesic. (Numeric Rating Scale, NRS, eleven-point scale reporting no pain=0, to maximum pain=10; 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain)
  • Analgesic, drug type [ Time Frame: 2000-2016 ]
    Use of analgesic (n= type of analgesic)
  • Analgesic, frequency [ Time Frame: 2000-2016 ]
    Use of analgesic (n= frequency how often analgesic is used)
  • Analgesic, amount of analgesics [ Time Frame: 2000-2016 ]
    Use of analgesic (n= amount of analgesic used in mg or µg)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 29, 2018)
  • Side effects [ Time Frame: 2000-2016 ]
    Type of side effect (respiratory arrest after use, hypoxemia, desaturation (SpO2<90%), dead)
  • Frequency of side effects [ Time Frame: 2000-2016 ]
    Frequency of side effects (frequency of side effect/n=total number of analgesic use; very common>=1/10, common>=1/100 and<1/10, uncommon >=1/1000 and <1/100, rare >=1/10000 and <1/1000, very rare <1/10000)
  • Severity of side effect [ Time Frame: 2000-2016 ]
    severity of side effect (0=none, 1=mild, 2=moderate, 3=severe, 4=potentially life threatening)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analgesia in ÖAMTC Helicopter Emergency Service in Austria
Official Title Analgesia in ÖAMTC Helicopter Emergency Service in Austria: A Retrospective Analysis
Brief Summary A sufficient analgesia in injured or sick people is the main goal of physicians treating a patient. In emergency medicine potent analgesia like ketamine or opioids are routinely used. It is unknown if there are any severe side effects or if the use is safe while in use in a Helicopter Emergency Service equipped with emergency physicians.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All patients screened with the described inclusion criteria - eligible to be included in analysis.
Condition
  • Field Physician Care
  • Analgesics
  • Hypnotics
  • Emergencies
  • Safety
  • Accident
  • Trauma, Multiple
  • Pain, Acute
Intervention
  • Other: analgesics
    analgesics given to a patient treated from HEMS
  • Other: hypnotics
    hypnotics given to a patient treated from HEMS
Study Groups/Cohorts Patient given analgesics or hypnotics
All patients treated with any kind of analgesics or hypnotics are analyzed and compared.
Interventions:
  • Other: analgesics
  • Other: hypnotics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 29, 2018)
35000
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2021
Actual Primary Completion Date October 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Analgesia or use of hypnotics in ÖAMTC Air Ambulance Service in Austria 2000-2016

Exclusion Criteria:

  • No analgesia, or analgesia use not in connection to ÖAMTC Air Ambulance Service. Analgesia given not in the period of examination (2000-2016)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT03760302
Other Study ID Numbers AN2015-0068 347/4.13 381/5.19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Medical University Innsbruck
Study Sponsor Medical University Innsbruck
Collaborators Not Provided
Investigators
Principal Investigator: Mathias Ströhle, Dr General and Surgical Critical Care Medicine, Medical University of Innsbruck
PRS Account Medical University Innsbruck
Verification Date May 2020