TraumaPhase 4TRAUMOXNCT03491644
Restrictive vs. Liberal Oxygen Therapy for Trauma Patients
A Phase 4 study testing Titrated Oxygen and Liberal Oxygen in people with Trauma and Wounds and Injuries, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Wounds and Injuries
- What is being tested?
- Titrated Oxygen and Liberal Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Apr 2018to 2 Jul 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients in cardiac arrest before/at admission
- Patients with a suspicion of smoke inhalation
- No hospital admission after initial treatment in trauma center
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restrictive vs. Liberal Oxygen Therapy for Trauma Patients. PILOT: The TRAUMOX Trial
The objective of this trial is to investigate whether treatment with oxygen in the early phases after a trauma plays a role in recovery.
Read the detailed description
Oxygen is probably the most frequently used drug both in the prehospital and emergency setting. It is cheap, easily administered, and, at least for shorter time frames, widely believed to be without any risk of harm.
Treatment with oxygen is indicated in the state of hypoxemia in order to prevent hypoxic organ damage, however, oxygen is administered in many other situations too, sometimes in a non-consistent manner and very often without even being prescribed.
Notably, administration of un-titrated oxygen, introduces a risk of hyperoxia which has been associated with serious adverse effects.
Retrospective studies on patients with cardiac arrest, myocardial infarction (MI) and traumatic brain injury have found hyperoxia to be associated with increased mortality and ICU length of stays.
A randomized trial also found an increased rate of recurrent myocardial infarction in a high-concentration oxygen group. Furthermore, in patients undergoing surgery, high intraoperative FiO2 has been associated with major respiratory complications and with 30-day mortality. In ICU patients, an observational study as well as a randomized trial found high levels of oxygen to be associated with higher mortality compared to conservative oxygen treatment. In particular, the randomized trial found that patients with PaO2 between 70 and 100 mmHg had a mortality of 11.6% compared to 20.2% in patients managed in accordance with standard ICU practice (which allows PaO2 up to 150mmHg) (p=0.01).
For people between the ages of 5 and 44 years, trauma is one of the top three causes of death. Almost twice as many men as women die as a result of trauma.
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.
In the trauma population, oxygen administration is often standard of care. However, the evidence supporting oxygen administration in this population appears to be extremely limited.
Nevertheless, absorption atelectases have been shown to develop within minutes under an oxygen fraction of 1.0, and are strongly related to the development of pneumonia. Indeed, a recent retrospective study found hyperoxemia to be an independent risk factor for ventilator associated pneumonia (VAP). As the incidences of hyperoxemia in mechanically ventilated patients range from 16-50% and the incidence of pneumonia in general in the Intensive Care Unit (ICU) is close to 26%, and reported to be up to twice as high in the trauma population, studies are warranted to establish the impact of a restricted, but sufficient, oxygen strategy vs a liberal oxygen strategy in the trauma population.
The primary objective of this trial is to evaluate whether the maintenance of pragmatic normoxia, avoiding both hyperoxic and hypoxic phases, is feasible within the first 24 hours after trauma, as it may result in a reduction of 30-day mortality and major respiratory complications within 30 days (respiratory failure, pulmonary edema, and pneumonia).
The investigators will therefore conduct a pilot study, where 40 evaluable patients are randomized to 24 hours of:
- A. Restrictive, but sufficient oxygen treatment:
- Lowest oxygen delivery that obtains a saturation of ≥ 94% (within the low limits of standard of care and does thus not put patients at risk of receiving worse treatment. Hypoxic phases will be avoided.)
- B. Liberal oxygen treatment:
- 15 L/min oxygen flow initially/ FiO2 ≥0.8. (Considered as close as possible to the standard of care. As no precise guidelines on oxygen delivery for trauma patients within the first 24 hours exist, this will however inevitably vary in practice. We have therefore set the delivery to be in the high end of the varying standard of care.)
The investigators hypothesize that hospitalized trauma patients treated with liberal oxygen therapy during the first 24 hours after trauma will have a greater risk of death and major respiratory complications compared to trauma patients treated with restrictive oxygen. The investigators realize that this cannot be assessed in this pilot study, but it is crucial to know if the study is feasible before doing a large and adequately powered trial.
Composite Primary Outcomes:
- 30-day mortality and major respiratory complications within 30 days (pneumonia, acute respiratory distress syndrome (ARDS), acute lung injury (ALI)).
Secondary Outcomes
- Intensive Care Unit length of stay (ICU LOS)
- Hospital length of Stay
- Days on ventilator
- 30 days post-trauma (through telephone follow-up if discharged)
- Glasgow Outcome Scale Extended (GOSE)
- Pneumonia
- Conditions
- Trauma, Wounds and Injuries
- Being tested
- Titrated Oxygen, Liberal Oxygen
- Keywords
- Traumatic accident, Oxygen, Intensive Care, Emergency
- Medical subject headings
- Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titrated OxygenDrug
Restrictive treatment with oxygen.
Liberal OxygenDrug
Liberal treatment with oxygen.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Titrated Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 30 days
Secondary outcomes (5)
Intensive Care Unit length of stay
Hours spent in the Intensive Care unit
Measured: From date of randomization until the date of first documented discharge from the intensive care unit, up to 100 months
Hospital length of Stay
Hours spent in the hospital
Measured: From date of randomization until the date of first documented discharge from the hospital, up to 100 months
Days on mechanical ventilation
Hours spent on mechanical ventilation
Measured: From date of randomization until the date of first documented extubation, up to 100 months
Glasgow Outcome Scale Extended (GOSE)
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
Measured: Assessed 30 days post-trauma (questionnaire through telephone follow-up if discharged)
Pneumonia
Simple questionnaire on whether treatment for pneumonia has been initiated.
Measured: 30 days post-trauma (questionnaire through telephone follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start3 Apr 2018
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josefine Stokholm Bækgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Josefine S Bækgaard, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletJacob Steinmetz, MD, PhD, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491644
- Sponsor's protocol ID
- 2017-991
- Acronym
- TRAUMOX
- Status last verified
- Aug 2018
- First submitted
- 19 Mar 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30908592
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restrictive vs. Liberal Oxygen Therapy for Trauma Patients. PILOT: The TRAUMOX Trial
- ClinicalTrials.gov ID
- NCT03491644
- Acronym / sponsor ID
- TRAUMOX / 2017-991
- Conditions
- Trauma, Wounds and Injuries
- Keywords
- Traumatic accident, Oxygen, Intensive Care, Emergency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to investigate whether treatment with oxygen in the early phases after a trauma plays a role in recovery.
Detailed description
Oxygen is probably the most frequently used drug both in the prehospital and emergency setting. It is cheap, easily administered, and, at least for shorter time frames, widely believed to be without any risk of harm.
Treatment with oxygen is indicated in the state of hypoxemia in order to prevent hypoxic organ damage, however, oxygen is administered in many other situations too, sometimes in a non-consistent manner and very often without even being prescribed.
Notably, administration of un-titrated oxygen, introduces a risk of hyperoxia which has been associated with serious adverse effects.
Retrospective studies on patients with cardiac arrest, myocardial infarction (MI) and traumatic brain injury have found hyperoxia to be associated with increased mortality and ICU length of stays.
A randomized trial also found an increased rate of recurrent myocardial infarction in a high-concentration oxygen group. Furthermore, in patients undergoing surgery, high intraoperative FiO2 has been associated with major respiratory complications and with 30-day mortality. In ICU patients, an observational study as well as a randomized trial found high levels of oxygen to be associated with higher mortality compared to conservative oxygen treatment. In particular, the randomized trial found that patients with PaO2 between 70 and 100 mmHg had a mortality of 11.6% compared to 20.2% in patients managed in accordance with standard ICU practice (which allows PaO2 up to 150mmHg) (p=0.01).
For people between the ages of 5 and 44 years, trauma is one of the top three causes of death. Almost twice as many men as women die as a result of trauma.
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.
In the trauma population, oxygen administration is often standard of care. However, the evidence supporting oxygen administration in this population appears to be extremely limited.
Nevertheless, absorption atelectases have been shown to develop within minutes under an oxygen fraction of 1.0, and are strongly related to the development of pneumonia. Indeed, a recent retrospective study found hyperoxemia to be an independent risk factor for ventilator associated pneumonia (VAP). As the incidences of hyperoxemia in mechanically ventilated patients range from 16-50% and the incidence of pneumonia in general in the Intensive Care Unit (ICU) is close to 26%, and reported to be up to twice as high in the trauma population, studies are warranted to establish the impact of a restricted, but sufficient, oxygen strategy vs a liberal oxygen strategy in the trauma population.
The primary objective of this trial is to evaluate whether the maintenance of pragmatic normoxia, avoiding both hyperoxic and hypoxic phases, is feasible within the first 24 hours after trauma, as it may result in a reduction of 30-day mortality and major respiratory complications within 30 days (respiratory failure, pulmonary edema, and pneumonia).
The investigators will therefore conduct a pilot study, where 40 evaluable patients are randomized to 24 hours of:
- A. Restrictive, but sufficient oxygen treatment:
- Lowest oxygen delivery that obtains a saturation of ≥ 94% (within the low limits of standard of care and does thus not put patients at risk of receiving worse treatment. Hypoxic phases will be avoided.)
- B. Liberal oxygen treatment:
- 15 L/min oxygen flow initially/ FiO2 ≥0.8. (Considered as close as possible to the standard of care. As no precise guidelines on oxygen delivery for trauma patients within the first 24 hours exist, this will however inevitably vary in practice. We have therefore set the delivery to be in the high end of the varying standard of care.)
The investigators hypothesize that hospitalized trauma patients treated with liberal oxygen therapy during the first 24 hours after trauma will have a greater risk of death and major respiratory complications compared to trauma patients treated with restrictive oxygen. The investigators realize that this cannot be assessed in this pilot study, but it is crucial to know if the study is feasible before doing a large and adequately powered trial.
Composite Primary Outcomes:
- 30-day mortality and major respiratory complications within 30 days (pneumonia, acute respiratory distress syndrome (ARDS), acute lung injury (ALI)).
Secondary Outcomes
- Intensive Care Unit length of stay (ICU LOS)
- Hospital length of Stay
- Days on ventilator
- 30 days post-trauma (through telephone follow-up if discharged)
- Glasgow Outcome Scale Extended (GOSE)
- Pneumonia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Liberal oxygen | Active comparator | Drug: Liberal OxygenLiberal 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. |
| Titrated oxygen | Experimental | Drug: Titrated OxygenTitrated 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients in cardiac arrest before/at admission
- Patients with a suspicion of smoke inhalation
- No hospital admission after initial treatment in trauma center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titrated OxygenRestrictive treatment with oxygen. | Drug | Titrated oxygen |
| Liberal OxygenLiberal treatment with oxygen. | Drug | Liberal oxygen |
Primary outcome
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)).
5 secondary outcomes
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
Hospital length of Stay
Time frame: From date of randomization until the date of first documented discharge from the hospital, up to 100 months
Days on mechanical ventilation
Time frame: From date of randomization until the date of first documented extubation, up to 100 months
Glasgow Outcome Scale Extended (GOSE)
Time frame: Assessed 30 days post-trauma (questionnaire through telephone follow-up if discharged)
Pneumonia
Time frame: 30 days post-trauma (questionnaire through telephone follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 30908592Baekgaard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josefine S Bækgaard, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Jacob Steinmetz, MD, PhD study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Titrated Oxygen and Liberal Oxygen in people with Trauma and Wounds and Injuries, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Primary Outcomes (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03491644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.