Wounds and InjuryNCT03191279
First Aid by Laypersons - Effect on Mortality and Length of Stay
An observational study of Wounds and Injury and First Aid, run by University of Tromso at 1 site in Norway.
Trial summary
The study aims to assess the effect of first aid from bystanders on survival, admission length, and need of ICU-stay for trauma victims. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wounds and Injury, First Aid, Bystander
- What is being tested?
- First aid
- Type of treatment
- Surgery or procedure
- How many people
- 1,400 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2018to Aug 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who has sustained an injury and where the EMS has been alerted and initiated an emergency response
Who may be able to join
- All emergency response calls to trauma (drownings and hangings included)
Who cannot join
- No injury to patient
- Non-traumatic condition
- Poisonings
Trial locations and contacts
1 site in 1 country.
Norway1 site
UNN Tromsø
Tromsø, 9037
Håkon Bakke, MD, PhD, +4795182294, hakonkvalebakke@gmail.com
About this study
Official title: Førstehjelp Gjort av Lekfolk-effekt på dødelighet og behandlingsforløp (First Aid by Laypersons - Effect on Mortality and Length of Stay)
The study aims to assess the effect of first aid from bystanders on survival, admission length, and need of ICU-stay for trauma victims.
Read the detailed description
All ambulance services in Norway will be invited to participate. In the participating ambulance services, the personnel of first unit to reach the scene of accident for any emergency response to trauma will register what first aid measures (if any) are indicated and have been performed by the bystanders on the scene up til the point where the ambulance arrives. Hospital data for each case will be retrieved. Those patients who did receive correct first aid will then be compared to those patients who did not receive first aid, and those where first aid was attempted but not correct for differences in share of survivors, length of hospital stay, and need for admission to ICU.
- Conditions
- Wounds and Injury, First Aid, Bystander, Trauma
- Being tested
- First aid
- Keywords
- Wounds and injury, Trauma, First aid, Bystander, Laypersons
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First aidProcedure or surgery
Open airway (head tilt, chin lift), recovery position, staunch of bleeding, prevention of hypothermia, cooling of burn, CPR
| Study group | Role | What they receive |
|---|---|---|
| First aid correct | Patient has received first aid according to local guidelines for all indicated first aid measures from bystanders on scene of accident when the first ambulance arrives Receives: Procedure: First aid | |
| First aid attempted | Bystanders have attempted first aid for indicated first aid measures, but measures have been incorrectly performed according to local guidelines Receives: Procedure: First aid | |
| No first aid | Indicated first aid measures have not been carried out when the first ambulance arrives on scene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission length
Length of hospital stay after injury, in days
Measured: 3 months after inclusion
Survival
30-day survival, starting from day of injury
Measured: 1 month after inclusion
Need of ICU stay
Whether patient is admitted to ICU during admission
Measured: 3 months after inclusion
Secondary outcomes (1)
Length of ICU stay
Length of ICU stay if patient was admitted to ICU, in days
Measured: 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study startAug 2018 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuryStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway, Norsk Folkehjelp, Nasjonal kompetansetjeneste for traumatologi (NKT-Traume)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191279
- Sponsor's protocol ID
- 2016/1760
- Status last verified
- Jun 2017
- First submitted
- 3 May 2017
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan of sharing IDP
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Førstehjelp Gjort av Lekfolk-effekt på dødelighet og behandlingsforløp (First Aid by Laypersons - Effect on Mortality and Length of Stay)
- ClinicalTrials.gov ID
- NCT03191279
- Acronym / sponsor ID
- 2016/1760
- Conditions
- Wounds and Injury, First Aid, Bystander, Trauma
- Keywords
- Wounds and injury, Trauma, First aid, Bystander, Laypersons
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- University Hospital of North Norway, Norsk Folkehjelp, Nasjonal kompetansetjeneste for traumatologi (NKT-Traume)
- Study start
- Aug 2018 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 19 Jun 2017 (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.
The study aims to assess the effect of first aid from bystanders on survival, admission length, and need of ICU-stay for trauma victims.
Detailed description
All ambulance services in Norway will be invited to participate. In the participating ambulance services, the personnel of first unit to reach the scene of accident for any emergency response to trauma will register what first aid measures (if any) are indicated and have been performed by the bystanders on the scene up til the point where the ambulance arrives. Hospital data for each case will be retrieved. Those patients who did receive correct first aid will then be compared to those patients who did not receive first aid, and those where first aid was attempted but not correct for differences in share of survivors, length of hospital stay, and need for admission to ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First aid correct | – | Procedure: First aidPatient has received first aid according to local guidelines for all indicated first aid measures from bystanders on scene of accident when the first ambulance arrives |
| First aid attempted | – | Procedure: First aidBystanders have attempted first aid for indicated first aid measures, but measures have been incorrectly performed according to local guidelines |
| No first aid | – | –Indicated first aid measures have not been carried out when the first ambulance arrives on scene |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who has sustained an injury and where the EMS has been alerted and initiated an emergency response
Key inclusion criteria (1 listed)
- All emergency response calls to trauma (drownings and hangings included)
Key exclusion criteria (3 listed)
- No injury to patient
- Non-traumatic condition
- Poisonings
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 |
|---|---|---|
| First aidOpen airway (head tilt, chin lift), recovery position, staunch of bleeding, prevention of hypothermia, cooling of burn, CPR | Procedure or surgery | First aid attempted, First aid correct |
Primary outcome
Admission length
Time frame: 3 months after inclusion
Length of hospital stay after injury, in days
Survival
Time frame: 1 month after inclusion
30-day survival, starting from day of injury
Need of ICU stay
Time frame: 3 months after inclusion
Whether patient is admitted to ICU during admission
1 secondary outcome
Length of ICU stay
Time frame: 3 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Individual participant dataSharing planned: No. No plan of sharing IDP
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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.
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 Wounds and Injury and First Aid, run by University of Tromso at 1 site in Norway.
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: status not confirmed, as of the sponsor's last update on 19 Jun 2017. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Håkon Kvåle Bakke, MD, PhD (+4795182294, hakonkvalebakke@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission length (time frame: 3 months after inclusion). The study lists 3 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 19 Jun 2017.