Restrictive vs. Liberal Oxygen Therapy for Trauma Patients

NCT03491644 | Completed Phase 4 DMC

• 1 other identifier: 2017-991
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma; Wounds and Injuries

Keywords

Traumatic accident; Oxygen; Intensive Care; Emergency

Outcome Measures

Primary Outcomes (1)

• Composite Primary Outcomes

  30-day mortality and major respiratory complications within 30 days (pneumonia (CDC criteria), acute respiratory distress syndrome (ARDS), acute lung injury (ALI)).

  30 days

Secondary Outcomes (5)

• Intensive Care Unit length of stay

  From date of randomization until the date of first documented discharge from the intensive care unit, up to 100 months

• Hospital length of Stay

  From date of randomization until the date of first documented discharge from the hospital, up to 100 months

• Days on mechanical ventilation

  From date of randomization until the date of first documented extubation, up to 100 months

• Glasgow Outcome Scale Extended (GOSE)

  Assessed 30 days post-trauma (questionnaire through telephone follow-up if discharged)

• Pneumonia

  30 days post-trauma (questionnaire through telephone follow-up)

Study Arms (2)

Liberal oxygen

ACTIVE COMPARATOR

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

Titrated oxygen

EXPERIMENTAL

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

Interventions

Titrated Oxygen DRUG

Restrictive treatment with oxygen.

Titrated oxygen

Liberal Oxygen DRUG

Liberal treatment with oxygen.

Liberal oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Baekgaard JS, Isbye D, Ottosen CI, Larsen MH, Andersen JH, Rasmussen LS, Steinmetz J. Restrictive vs liberal oxygen for trauma patients-the TRAUMOX1 pilot randomised clinical trial. Acta Anaesthesiol Scand. 2019 Aug;63(7):947-955. doi: 10.1111/aas.13362. Epub 2019 Mar 25.

  PMID: 30908592 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Josefine S Bækgaard, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Jacob Steinmetz, MD, PhD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (MD)

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 9, 2018
• Study Start: April 3, 2018
• Primary Completion: July 2, 2018
• Study Completion: July 2, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)