- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03191279
First Aid by Laypersons - Effect on Mortality and Length of Stay
June 15, 2017 updated by: University of Tromso
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
1400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Håkon Kvåle Bakke, MD, PhD
- Phone Number: +4795182294
- Email: hakonkvalebakke@gmail.com
Study Locations
-
-
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Tromso, Norway, 9037
- UNN Tromsø
-
Contact:
- Håkon Bakke, MD, PhD
- Phone Number: +4795182294
- Email: hakonkvalebakke@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients who has sustained an injury and where the EMS has been alerted and initiated an emergency response
Description
Inclusion Criteria:
- All emergency response calls to trauma (drownings and hangings included)
Exclusion Criteria:
- No injury to patient
- Non-traumatic condition
- Poisonings
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
Open airway (head tilt, chin lift), recovery position, staunch of bleeding, prevention of hypothermia, cooling of burn, CPR
|
First aid attempted
Bystanders have attempted first aid for indicated first aid measures, but measures have been incorrectly performed according to local guidelines
|
Open airway (head tilt, chin lift), recovery position, staunch of bleeding, prevention of hypothermia, cooling of burn, CPR
|
No first aid
Indicated first aid measures have not been carried out when the first ambulance arrives on scene
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Admission length
Time Frame: 3 months after inclusion
|
Length of hospital stay after injury, in days
|
3 months after inclusion
|
Survival
Time Frame: 1 month after inclusion
|
30-day survival, starting from day of injury
|
1 month after inclusion
|
Need of ICU stay
Time Frame: 3 months after inclusion
|
Whether patient is admitted to ICU during admission
|
3 months after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of ICU stay
Time Frame: 3 months after inclusion
|
Length of ICU stay if patient was admitted to ICU, in days
|
3 months after inclusion
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whether patients received first aid from bystanders
Time Frame: At time of inclusion
|
If patients with indicated measures receiving first aid from bystanders, given for each measure and combined
|
At time of inclusion
|
Whether first aid measures were indicated for the patient
Time Frame: At time of inclusion
|
If first aid measures was indicated, given for each measure and combined
|
At time of inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2018
Primary Completion (Anticipated)
August 1, 2020
Study Completion (Anticipated)
August 1, 2021
Study Registration Dates
First Submitted
May 3, 2017
First Submitted That Met QC Criteria
June 15, 2017
First Posted (Actual)
June 19, 2017
Study Record Updates
Last Update Posted (Actual)
June 19, 2017
Last Update Submitted That Met QC Criteria
June 15, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/1760
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No plan of sharing IDP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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