## Protocol Section
### Identification Module
**NCT ID:** NCT03191279

**Brief Title:** First Aid by Laypersons - Effect on Mortality and Length of Stay

**Official Title:** Førstehjelp Gjort av Lekfolk-effekt på dødelighet og behandlingsforløp (First Aid by Laypersons - Effect on Mortality and Length of Stay)

#### Organization Study ID Info
**ID:** 2016/1760
#### Organization
**Class:** OTHER
**Full Name:** University of Tromso
### Status Module
#### Completion Date
**Date:** 2021-08

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2017-06-19

**Type:** ACTUAL

**Last Update Submit Date:** 2017-06-15

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-08

**Type:** ESTIMATED

**Status Verified Date:** 2017-06

#### Study First Post Date
**Date:** 2017-06-19
**Type:** ACTUAL
**Study First Submit Date:** 2017-05-03
**Study First Submit QC Date:** 2017-06-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University Hospital of North Norway

**Class:** UNKNOWN

**Name:** Norsk Folkehjelp

**Class:** UNKNOWN

**Name:** Nasjonal kompetansetjeneste for traumatologi (NKT-Traume)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Tromso

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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 Module

**Conditions:**

- Wounds and Injury

- First Aid

- Bystander

- Trauma

**Keywords:**

- Wounds and injury

- Trauma

- First aid

- Bystander

- Laypersons

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1400

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Procedure: First aid

**Label:** First aid correct

#### Arm Group 2

**Description:** Bystanders have attempted first aid for indicated first aid measures, but measures have been incorrectly performed according to local guidelines

**Intervention Names:**

- Procedure: First aid

**Label:** First aid attempted

#### Arm Group 3

**Description:** Indicated first aid measures have not been carried out when the first ambulance arrives on scene

**Label:** No first aid

### Interventions

#### Intervention 1

**Arm Group Labels:**

- First aid attempted

- First aid correct

**Description:** Open airway (head tilt, chin lift), recovery position, staunch of bleeding, prevention of hypothermia, cooling of burn, CPR

**Name:** First aid

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** If patients with indicated measures receiving first aid from bystanders, given for each measure and combined

**Measure:** Whether patients received first aid from bystanders

**Time Frame:** At time of inclusion

**Description:** If first aid measures was indicated, given for each measure and combined

**Measure:** Whether first aid measures were indicated for the patient

**Time Frame:** At time of inclusion

#### Primary Outcomes

**Description:** Length of hospital stay after injury, in days

**Measure:** Admission length

**Time Frame:** 3 months after inclusion

**Description:** 30-day survival, starting from day of injury

**Measure:** Survival

**Time Frame:** 1 month after inclusion

**Description:** Whether patient is admitted to ICU during admission

**Measure:** Need of ICU stay

**Time Frame:** 3 months after inclusion

#### Secondary Outcomes

**Description:** Length of ICU stay if patient was admitted to ICU, in days

**Measure:** Length of ICU stay

**Time Frame:** 3 months after inclusion

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* All emergency response calls to trauma (drownings and hangings included)

Exclusion Criteria:

* No injury to patient
* Non-traumatic condition
* Poisonings

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hakonkvalebakke@gmail.com

**Name:** Håkon Kvåle Bakke, MD, PhD

**Phone:** +4795182294

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tromso

**Contacts:**

***Contact 1:***

- **Email:** hakonkvalebakke@gmail.com

- **Name:** Håkon Bakke, MD, PhD

- **Phone:** +4795182294

- **Role:** CONTACT

**Country:** Norway

**Facility:** UNN Tromsø

**Zip:** 9037

### IPD Sharing Statement Module

**Description:** No plan of sharing IDP

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Wounds and Injuries

### Condition Browse Module - Meshes

- ID: D000014947

- Term: Wounds and Injuries

### Misc Info Module

- Version Holder: 2024-05-24
