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Restrictive vs. Liberal Oxygen Therapy for Trauma Patients (TRAUMOX)

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ClinicalTrials.gov Identifier: NCT03491644
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Josefine Stokholm Bækgaard, Rigshospitalet, Denmark

Brief Summary:
The objective of this trial is to investigate whether treatment with oxygen in the early phases after a trauma plays a role in recovery.

Condition or disease Intervention/treatment Phase
Trauma Wounds and Injuries Drug: Titrated Oxygen Drug: Liberal Oxygen Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Intervention: restrictive oxygen treatment for the first 24 hours. This implies administration of the lowest dosage of oxygen possible in order to achieve a saturation of 94%, using mechanical ventilation (intubated patients), a nasal cannula, a non-rebreather or nothing. A saturation above 94% shall not be aimed for using supplemental oxygen, and thus only patients without oxygen requirement shall have saturations above 94%.

Control: liberal oxygen treatment for the first 24 hours. In the trauma bay and during intrahospital transportation this implies an FiO2 of 1.0 for intubated patients and an oxygen flow on a non-rebreather with reservoir of 15 l/min for non-intubated patients. In the OR, patients will receive a FiO2 of ≥ 0.8 to obtain a saturation of ≥ 98%. Patients admitted to the ICU/PACU/floor will receive and FiO2 of ≥ 0.8 or more to obtain a saturation of ≥ 98% when intubated and for non-intubated patients a non-rebreather with reservoir will be set to 15 l/min.

Masking: Single (Outcomes Assessor)
Masking Description:

The study will be an open-label randomized clinical trial with regards to treatment: treating staff will be aware of the patient's randomization group.

Outcome assessors (attending anesthesiologist for pneumonia and research assistant for long term outcomes (GOSE after 30 days, ARDS* within 30 days, pneumonia diagnosed after discharge within 30 days)) will be blinded to the patients' randomization.

To ensure blinding, prior to assessing the outcomes, all information indicative of the allocation will be censured by the PI.

To validate the blinding, the attending anesthesiologist and research assistant assessing outcome variables will be asked to guess which group of randomization the patient is in.

ARDS: PaO2/FiO2 will be calculated for the assessor in order to maintain blinding.

Primary Purpose: Prevention
Official Title: Restrictive vs. Liberal Oxygen Therapy for Trauma Patients. PILOT: The TRAUMOX Trial
Actual Study Start Date : April 3, 2018
Actual Primary Completion Date : July 2, 2018
Actual Study Completion Date : July 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Liberal oxygen

Liberal oxygen administration (to mimic current practice) for the first 24 hours without interruption.

In the trauma bay and during intrahospital transportation this implies administration of a FiO2 of 1.0 for intubated patients and an oxygen flow on a non-rebreather with reservoir of 15 l/min for non-intubated patients. In the operating room, patients will receive a FiO2 of ≥ 0.8 to obtain a saturation of ≥ 98%. Patients admitted to the ICU/PACU/floor will receive and FiO2 of ≥ 0.8 or more to obtain a saturation of ≥ 98% when intubated and for non-intubated patients a non-rebreather with reservoir will be set to 15 l/min.

Drug: Liberal Oxygen
Liberal treatment with oxygen.

Experimental: Titrated oxygen

Titrated oxygen administration for the first 24 hours without interruption. Lowest dosage of oxygen possible in order to achieve a saturation of at least 94%, either using mechanical ventilation (intubated patients), a nasal cannula, a non-rebreather or nothing.

A saturation above 94% shall not be aimed for using supplemental oxygen, and thus only patients without oxygen requirement shall have saturations above 94%.

The intervention will only be interrupted in case the saturation becomes unmeasurable - if this happens, the treating physician shall treat the patient as he/she judges best fit. As soon as the saturation is measurable again, the intervention will resume. The treating physician must document and explain the situation.

Drug: Titrated Oxygen
Restrictive treatment with oxygen.




Primary Outcome Measures :
  1. Composite Primary Outcomes [ Time Frame: 30 days ]
    30-day mortality and major respiratory complications within 30 days (pneumonia (CDC criteria), acute respiratory distress syndrome (ARDS), acute lung injury (ALI)).


Secondary Outcome Measures :
  1. Intensive Care Unit length of stay [ Time Frame: From date of randomization until the date of first documented discharge from the intensive care unit, up to 100 months ]
    Hours spent in the Intensive Care unit

  2. Hospital length of Stay [ Time Frame: From date of randomization until the date of first documented discharge from the hospital, up to 100 months ]
    Hours spent in the hospital

  3. Days on mechanical ventilation [ Time Frame: From date of randomization until the date of first documented extubation, up to 100 months ]
    Hours spent on mechanical ventilation

  4. Glasgow Outcome Scale Extended (GOSE) [ Time Frame: Assessed 30 days post-trauma (questionnaire through telephone follow-up if discharged) ]
    Eight point grading scale of recovery levels assessed through a questionnaire. 1= death, 2=vegetative state, 3=lower severe disability, 4=upper severe disability, 5=lower moderate disability, 6=upper moderate disability, 7=lower good recovery, 8=upper good recovery

  5. Pneumonia [ Time Frame: 30 days post-trauma (questionnaire through telephone follow-up) ]
    Simple questionnaire on whether treatment for pneumonia has been initiated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491644


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Josefine S Bækgaard, MD Rigshospitalet, Denmark
Study Director: Jacob Steinmetz, MD, PhD Rigshospitalet, Denmark

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Responsible Party: Josefine Stokholm Bækgaard, Medical Doctor (MD), Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03491644     History of Changes
Other Study ID Numbers: 2017-991
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Josefine Stokholm Bækgaard, Rigshospitalet, Denmark:
Traumatic accident
Oxygen
Intensive Care
Emergency
Additional relevant MeSH terms:
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Wounds and Injuries