EUCTR2017-004480-12-DK
Active, not recruiting
Phase 1
Restrictive vs. Liberal Oxygen Therapy for Trauma patients. PILOT: TheTRAUMOX Trial - TRAUMOX trial
ConditionsVictims 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 lifeMedDRA version: 20.0Level: LLTClassification code 10050322Term: Oxygen supplementationSystem Organ Class: 100000004865MedDRA version: 20.0Level: LLTClassification code 10033321Term: Oxygen saturation lowSystem Organ Class: 100000004848MedDRA version: 20.0Level: LLTClassification code 10033323Term: Oxygen tensionSystem Organ Class: 100000004848MedDRA version: 20.0Level: LLTClassification code 10033324Term: Oxygen tension abnormal NOSSystem Organ Class: 100000004848MedDRA version: 20.0Level: LLTClassification code 10033325Term: Oxygen tension decreasedSystem Organ Class: 100000004848MedDRA version: 20.0Level: LLTClassification code 10033326Term: Oxygen tension increasedSystem Organ Class: 100000004848MedDRA version: 20.0Level: LLTClassification code 10033327Term: Oxygen tension normalSystem Organ Class: 100000004848MedDRA version: 20.0Level: LLTClassification code 10033319Term: Oxygen saturation highSystem Organ Class: 100000004848MedDRA version: 20.0Level: LLTClassification code 10059945Term: Partial arterial pressure of oxygenSystem Organ Class: 100000004848MedDRA version: 20.1Level: LLTClassification code 10068430Term: Arterial oxygen saturationSystem Organ Class: 100000004848MedDRA version: 20.1Level: LLTClassification code 10068431Term: Arterial oxygen saturation increasedSystem Organ Class: 100000004848MedDRA version: 20.1Level: LLTClassification code 10068432Term: Arterial oxygen saturation decreasedSystem Organ Class: 100000004848MedDRA version: 20.Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsOxygen
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- 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
- Sponsor
- Rigshospitalet
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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