TraumaNCT03789396
Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
An observational study of Trauma and Critical Illness, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The objective of this study is to conduct an observational pre/post study to evaluate the clinical impact oxygen guideline implementation on oxygen utilization and oxygenation in critically ill trauma patients. Read more about this study
- Who is it for?
- Ages 18 to 109 years
- Conditions the study is for
- Trauma, Critical Illness, Oxygen Toxicity
- What is being tested?
- Targeted Normoxia (oxygen saturation 90-96%)
- How many people
- 572 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 Oct 2022
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 109 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill trauma patients
Who may be able to join
- Acute Injury/Trauma
- Arrival to Emergency Department
Who cannot join
- <18 years of age
- Known prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
The objective of this study is to conduct an observational pre/post study to evaluate the clinical impact oxygen guideline implementation on oxygen utilization and oxygenation in critically ill trauma patients.
Read the detailed description
Supplemental oxygen is fundamental in caring for critically ill trauma. While the avoidance of hypoxia is vital, the current clinical practice of excessive oxygenation settings is common, and unnecessary, and may even be harmful.
An expert panel convened to define optimal oxygenation targets in critically ill trauma patients. The strong consensus was to target normoxia at an oxygen saturation (SpO2) range of 90-96% and arterial oxygen (PaO2) range of 60-100 mmHg. Accordingly, a pilot trial implementation of this consensus will occur for the care of trauma patients.
Specific Aim:
This is an observational pre/post study to evaluate the impact of targeted normoxia implementation in optimizing oxygen delivery and oxygenation in critically ill trauma patients.
Hypotheses:
That the clinical efforts to improve adherence to oxygen guidelines will:
- improve the proportion of time spent with target normoxia thresholds (oxygen saturation SpO2 90-96%) by
- reducing utilization of unnecessary supplementation oxygen
- without a substantive increase in hypoxic episodes or an adverse impact on clinical outcomes.
- Conditions
- Trauma, Critical Illness, Oxygen Toxicity
- Being tested
- Targeted Normoxia (oxygen saturation 90-96%), Usual Care Oxygenation
- Keywords
- Oxygenation, Hypoxia, Normoxia, Hyperoxia, Trauma, Critical Illness
- Medical subject headings
- Wounds and Injuries, Critical Illness, Hypoxia, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Normoxia (oxygen saturation 90-96%)Other
The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation
Usual Care OxygenationOther
The control (pre-implementation) group will be trauma patients admitted to the ICU during the 12 months prior to the targeted normoxia implementation
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation | The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia Receives: Other: Usual Care Oxygenation | |
| Post-implementation | The intervention group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation. Receives: Other: Targeted Normoxia (oxygen saturation 90-96%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-time Hyperoxic and Not on Room Air
Total percentage of patient-time hyperoxic and not on room air: total time spent by patients in a hyperoxic state while receiving supplemental oxygen, divided by total patient time on study
Measured: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days from dates Jan. 1, 2018 to July 1, 2019
Secondary outcomes (9)
Episodes of Hypoxia (SpO2< 88%)
SpO2 saturations below 88%. Episodes of hypoxia reported in minutes (i.e. one episode of hypoxia = one minute spent).
Measured: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
Episodes of Hyperoxia (SpO2 >96%)
SpO2 saturations above 96%. Episodes of hyperoxia reported in minutes (i.e. one episode of hyperoxia = one minute spent).
Measured: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
Ventilator Free Day
Ventilator Free Days = Days off ventilator
Measured: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
Time to Room Air
Duration of supplemental oxygen use measured in days
Measured: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
Measured by Daily Sequential Organ Failure Assessment (SOFA)
Acute organ injury as measured by SOFA score
Measured: First 7 days of hospitalization
ICU Length of Stay
Number of days spent in the ICU
Measured: From time of emergency department arrival until the date of ICU discharge or death, assessed up to 180 days
Hospital Length of Stay
Number of days spent in the hospital
Measured: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days
Hospital Discharge Disposition
Percent of patients discharged to home or facility vs death or hospice = measuring illness at discharge
Measured: Date of hospital discharge, assessed up to 180 days
Hospital Mortality
Percent of deceased participants
Measured: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 Jan 2018
- Primary completion19 Sep 2019
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 University of Colorado, DenverThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 572 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Adit Ginde, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789396
- Sponsor's protocol ID
- 18-1528
- Status last verified
- Jun 2023
- First submitted
- 13 Dec 2018
- Last updated
- 15 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuroda N, Tsutsumi Y, Banno M. Does statistical difference in the pre/post-quasi-experimental study mean the utility of multimodal educational intervention in targeted normoxia in critically ill trauma patients? J Trauma Acute Care Surg. 2021 Aug 1;91(2S Suppl 2):S269-S270. doi: 10.1097/TA.0000000000003301. No abstract available.
PubMed 34039929
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
- ClinicalTrials.gov ID
- NCT03789396
- Acronym / sponsor ID
- 18-1528
- Conditions
- Trauma, Critical Illness, Oxygen Toxicity
- Keywords
- Oxygenation, Hypoxia, Normoxia, Hyperoxia, Trauma, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 28 Dec 2018 (actual)
- Results
- Posted 15 Feb 2024
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 study is to conduct an observational pre/post study to evaluate the clinical impact oxygen guideline implementation on oxygen utilization and oxygenation in critically ill trauma patients.
Detailed description
Supplemental oxygen is fundamental in caring for critically ill trauma. While the avoidance of hypoxia is vital, the current clinical practice of excessive oxygenation settings is common, and unnecessary, and may even be harmful.
An expert panel convened to define optimal oxygenation targets in critically ill trauma patients. The strong consensus was to target normoxia at an oxygen saturation (SpO2) range of 90-96% and arterial oxygen (PaO2) range of 60-100 mmHg. Accordingly, a pilot trial implementation of this consensus will occur for the care of trauma patients.
Specific Aim:
This is an observational pre/post study to evaluate the impact of targeted normoxia implementation in optimizing oxygen delivery and oxygenation in critically ill trauma patients.
Hypotheses:
That the clinical efforts to improve adherence to oxygen guidelines will:
- improve the proportion of time spent with target normoxia thresholds (oxygen saturation SpO2 90-96%) by
- reducing utilization of unnecessary supplementation oxygen
- without a substantive increase in hypoxic episodes or an adverse impact on clinical outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation | – | Other: Usual Care OxygenationThe control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia |
| Post-implementation | – | Other: Targeted Normoxia (oxygen saturation 90-96%)The intervention group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation. |
Who may qualify
- Ages
- 18 to 109 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill trauma patients
Key inclusion criteria (2 listed)
- Acute Injury/Trauma
- Arrival to Emergency Department
Key exclusion criteria (2 listed)
- <18 years of age
- Known prisoners
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 |
|---|---|---|
| Targeted Normoxia (oxygen saturation 90-96%)The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation | Other | Post-implementation |
| Usual Care OxygenationThe control (pre-implementation) group will be trauma patients admitted to the ICU during the 12 months prior to the targeted normoxia implementation | Other | Pre-implementation |
Primary outcome
Patient-time Hyperoxic and Not on Room Air
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days from dates Jan. 1, 2018 to July 1, 2019
Total percentage of patient-time hyperoxic and not on room air: total time spent by patients in a hyperoxic state while receiving supplemental oxygen, divided by total patient time on study
9 secondary outcomes
Episodes of Hypoxia (SpO2< 88%)
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
Episodes of Hyperoxia (SpO2 >96%)
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
Ventilator Free Day
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
Time to Room Air
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
Measured by Daily Sequential Organ Failure Assessment (SOFA)
Time frame: First 7 days of hospitalization
ICU Length of Stay
Time frame: From time of emergency department arrival until the date of ICU discharge or death, assessed up to 180 days
Hospital Length of Stay
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days
Hospital Discharge Disposition
Time frame: Date of hospital discharge, assessed up to 180 days
Hospital Mortality
Time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34039929Kuroda N, Tsutsumi Y, Banno M. Does statistical difference in the pre/post-quasi-experimental study mean the utility of multimodal educational intervention in targeted normoxia in critically ill trauma patients? J Trauma Acute Care Surg. 2021 Aug 1;91(2S Suppl 2):S269-S270. doi: 10.1097/TA.0000000000003301. No abstract available.
- 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.
Adit Ginde, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Critical Illness, run by University of Colorado, Denver at 1 site in United States.
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 2 inclusion and 2 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 15 Feb 2024. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient-time Hyperoxic and Not on Room Air (time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days from dates Jan. 1, 2018 to July 1, 2019). 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 NCT03789396, 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 15 Feb 2024.