Field Physician CareNCT03760302
Analgesia in ÖAMTC Helicopter Emergency Service in Austria
An observational study of Field Physician Care and Analgesics, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Field Physician Care, Analgesics, Hypnotics
- What is being tested?
- analgesics and hypnotics
- How many people
- 35,000 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2018to 26 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients screened with the described inclusion criteria - eligible to be included in analysis.
Who may be able to join
- Analgesia or use of hypnotics in ÖAMTC Air Ambulance Service in Austria 2000-2016
Who cannot join
- No analgesia, or analgesia use not in connection to ÖAMTC Air Ambulance Service. Analgesia given not in the period of examination (2000-2016)
Trial locations and contacts
1 site in 1 country.
Austria1 site
General and Surgical Critical Care Medicine, Medical University of Innsbruck
Innsbruck, 6020
About this study
Official title: Analgesia in ÖAMTC Helicopter Emergency Service in Austria: A Retrospective Analysis
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.
- Conditions
- Field Physician Care, Analgesics, Hypnotics, Emergencies, Safety, Accident
- Being tested
- analgesics, hypnotics
- Medical subject headings
- Emergencies, Multiple Trauma, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analgesicsOther
analgesics given to a patient treated from HEMS
hypnoticsOther
hypnotics given to a patient treated from HEMS
| Study group | Role | What they receive |
|---|---|---|
| Patient given analgesics or hypnotics | All patients treated with any kind of analgesics or hypnotics are analyzed and compared. Receives: Other: analgesics; Other: hypnotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful analgesia
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)
Measured: 2000-2016
Analgesic, drug type
Use of analgesic (n= type of analgesic)
Measured: 2000-2016
Analgesic, frequency
Use of analgesic (n= frequency how often analgesic is used)
Measured: 2000-2016
Analgesic, amount of analgesics
Use of analgesic (n= amount of analgesic used in mg or µg)
Measured: 2000-2016
Secondary outcomes (3)
Side effects
Type of side effect (respiratory arrest after use, hypoxemia, desaturation (SpO2<90%), dead)
Measured: 2000-2016
Frequency of side effects
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)
Measured: 2000-2016
Severity of side effect
severity of side effect (0=none, 1=mild, 2=moderate, 3=severe, 4=potentially life threatening)
Measured: 2000-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Dec 2018
- Primary completion26 Oct 2019
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Field Physician CareStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 35,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathias Ströhle, Dr, Principal investigator, General and Surgical Critical Care Medicine, Medical University of Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760302
- Sponsor's protocol ID
- AN2015-0068 347/4.13 381/5.19
- Status last verified
- Sep 2021
- First submitted
- 26 Nov 2018
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia in ÖAMTC Helicopter Emergency Service in Austria: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03760302
- Acronym / sponsor ID
- AN2015-0068 347/4.13 381/5.19
- Conditions
- Field Physician Care, Analgesics, Hypnotics, Emergencies, Safety, Accident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35,000 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 26 Oct 2019 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient given analgesics or hypnotics | – | Other: analgesics, Other: hypnoticsAll patients treated with any kind of analgesics or hypnotics are analyzed and compared. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients screened with the described inclusion criteria - eligible to be included in analysis.
Key inclusion criteria (1 listed)
- Analgesia or use of hypnotics in ÖAMTC Air Ambulance Service in Austria 2000-2016
Key exclusion criteria (1 listed)
- No analgesia, or analgesia use not in connection to ÖAMTC Air Ambulance Service. Analgesia given not in the period of examination (2000-2016)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analgesicsanalgesics given to a patient treated from HEMS | Other | Patient given analgesics or hypnotics |
| hypnoticshypnotics given to a patient treated from HEMS | Other | Patient given analgesics or hypnotics |
Primary outcome
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)
3 secondary outcomes
Side effects
Time frame: 2000-2016
Frequency of side effects
Time frame: 2000-2016
Severity of side effect
Time frame: 2000-2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Ströhle, Dr principal investigator
General and Surgical Critical Care Medicine, Medical University of Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Field Physician Care and Analgesics, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful analgesia (time frame: 2000-2016). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.