One-year Outcome After Prehospital IntubationNCT02307123
One-year Outcome After Prehospital Intubation
An observational study of One-year Outcome After Prehospital Intubation, run by Tampere University Hospital.
Trial summary
The primary aim of this study was to describe the long-term outcome of critically ill or severely injured patients not in cardiac arrest treated by an EMS physician. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- One-year Outcome After Prehospital Intubation
- What is being tested?
- Intubation
- Type of treatment
- Surgery or procedure
- How many people
- 483 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Apr 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All non-cardiac arrest patients, whose airway was secured by the HEMS physician.
Who may be able to join
- All non-cardiac arrest patients.
Who cannot join
- Patients with a known need for personal assistance in activities of daily life prior to the incident leading to prehospital intubation (outcome evaluation).
- Patients intubated by EMS before HEMS arrival.
- Death on scene or during transportation.
About this study
The primary aim of this study was to describe the long-term outcome of critically ill or severely injured patients not in cardiac arrest treated by an EMS physician.
Read the detailed description
The aim of helicopter emergency medical services (HEMS) is to supplement ground EMS units in the care of prehospital patients. The need for advanced airway management in critical out-of-hospital patients can be considered as one indicator of the severity of the patient's condition.
A recent European initiative suggested advanced airway management to be included in the top five research priorities for physician-provided prehospital care.To our knowledge, no previous studies describe the long-term outcome of critical prehospital patients treated by an EMS physician.
The primary aim of this study was to describe the long-term outcome of critically ill or severely injured patients not in cardiac arrest treated by an EMS physician. Our secondary aims were to determine the indications and causes for EMS physician performed prehospital endotracheal intubation.
- Being tested
- Intubation
- Keywords
- Prehospital emergency care (MeSH), Emergency medical services (MeSH), Helicopter emergency medical service, Critical care (MeSH), Airway management (MeSH), Endotracheal intubation (MeSH), Patient outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntubationProcedure or surgery
HEMS physician prehospital intubation
| Study group | Role | What they receive |
|---|---|---|
| HEMS treated patients | Patients whose airways were secured by the HEMS physician. Receives: Procedure: Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 1 year
Secondary outcomes (1)
Glasgow Outcome Score (GOS)
GOS 1 = Death GOS 2 = Poor neurological outcome GOS 3 = Good neurological outcome Modified from the original 5 - step classification.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for One-year Outcome After Prehospital IntubationStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toni Pakkanen, MD, Tampere University Hospital
- Investigators
- Arvi Yli-Hankala, professor, Study director, Tampere University HospitalToni VS Pakkanen, MD, Principal investigator, Tampere University HospitalIlkka Virkkunen, MD, PhD, Study chair, Tampere University HospitalTom Silfvast, MD, PhD, Study chair, Helsinki University Central HospitalTarja Randell, MD, PhD, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307123
- Sponsor's protocol ID
- 9N088
- Status last verified
- Dec 2015
- First submitted
- 30 Nov 2014
- Last updated
- 22 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Outcome After Prehospital Intubation
- ClinicalTrials.gov ID
- NCT02307123
- Acronym / sponsor ID
- 9N088
- Keywords
- Prehospital emergency care (MeSH), Emergency medical services (MeSH), Helicopter emergency medical service, Critical care (MeSH), Airway management (MeSH), Endotracheal intubation (MeSH), Patient outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Posted 22 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study was to describe the long-term outcome of critically ill or severely injured patients not in cardiac arrest treated by an EMS physician.
Detailed description
The aim of helicopter emergency medical services (HEMS) is to supplement ground EMS units in the care of prehospital patients. The need for advanced airway management in critical out-of-hospital patients can be considered as one indicator of the severity of the patient's condition.
A recent European initiative suggested advanced airway management to be included in the top five research priorities for physician-provided prehospital care.To our knowledge, no previous studies describe the long-term outcome of critical prehospital patients treated by an EMS physician.
The primary aim of this study was to describe the long-term outcome of critically ill or severely injured patients not in cardiac arrest treated by an EMS physician. Our secondary aims were to determine the indications and causes for EMS physician performed prehospital endotracheal intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEMS treated patients | – | Procedure: IntubationPatients whose airways were secured by the HEMS physician. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All non-cardiac arrest patients, whose airway was secured by the HEMS physician.
Key inclusion criteria (1 listed)
- All non-cardiac arrest patients.
Key exclusion criteria (3 listed)
- Patients with a known need for personal assistance in activities of daily life prior to the incident leading to prehospital intubation (outcome evaluation).
- Patients intubated by EMS before HEMS arrival.
- Death on scene or during transportation.
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 |
|---|---|---|
| IntubationHEMS physician prehospital intubation | Procedure or surgery | HEMS treated patients |
Primary outcome
Mortality
Time frame: 1 year
1 secondary outcome
Glasgow Outcome Score (GOS)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Arvi Yli-Hankala, professor study director
Tampere University Hospital
Toni VS Pakkanen, MD principal investigator
Tampere University Hospital
Ilkka Virkkunen, MD, PhD study chair
Tampere University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of One-year Outcome After Prehospital Intubation, run by Tampere University Hospital.
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 3 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 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 22 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mortality (time frame: 1 year). 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 22 Dec 2016; AzTrials last refreshed its copy on 6 Nov 2026.