Restrictive or Liberal Oxygen Therapy for Trauma patients

Phase 1

Conditions: MedDRA version: 20.0Level: LLTClassification code 10033325Term: Oxygen tension decreasedSystem Organ Class: 100000004848
Victims of trauma are often healthy individuals prior to the incident, but acquire numerous complications including sepsis and pulmonary complications as well as long-term complications and diminished quality of life after the trauma. Understanding the reasons behind these complications and poor outcomes and optimizing care is therefore essential to increase survival rates and quality of life
MedDRA version: 20.0Level: LLTClassification code 10033326Term: Oxygen tension increasedSystem Organ Class: 100000004848
MedDRA version: 20.0Level: LLTClassification code 10033319Term: Oxygen saturation highSystem Organ Class: 100000004848
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
MedDRA version: 20.0Level: LLTClassification code 10050322Term: Oxygen supplementationSystem Organ Class: 100000004865
MedDRA version: 20.0Level: LLTClassification code 10033323Term: Oxygen tensionSystem Organ Class: 100000004848
MedDRA version: 20.1Level: LLTClassification code 10068431Term: Arterial oxygen saturation increasedSystem Organ Class: 100000004848
MedDRA version: 20.0Level: LLTClassification code 10033324Term: Oxygen tension abnormal NOSSystem Organ Class: 100000004848
MedDRA version: 20.1Level: LLTClassification code 10068430Term: Arterial oxygen saturationSystem Organ Class: 100000004848

Registration Number: EUCTR2017-004480-12-DK

Lead Sponsor: Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria
-Age = 18 years, including fertile women*
-Blunt/Penetrating trauma patient
-Direct transfer from the scene of the accident to Rigshospitalets Traume Center
-Trauma team activation
* There is no added risk for enrolment of fertile women as oxygen administration is approved for this group of patients.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Exclusion Criteria
-Patients in cardiac arrest before/at admission
-Patients with a suspicion of smoke inhalation
-No hospital admission after initial treatment in trauma center