Clinical trial NCT03789396: Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
Official title: Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Critical Illness
Oxygen Toxicity
Keywords: Oxygenation
Hypoxia
Normoxia
Hyperoxia
Trauma
Critical Illness
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-12-28
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Maximum age (years): 109
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill trauma patients

Brief 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.

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:

1. improve the proportion of time spent with target normoxia thresholds (oxygen saturation SpO2 90-96%) by
2. reducing utilization of unnecessary supplementation oxygen
3. without a substantive increase in hypoxic episodes or an adverse impact on clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Acute Injury/Trauma
* Arrival to Emergency Department

Exclusion Criteria:

* \<18 years of age
* Known prisoners

Primary outcomes:
measure: Patient-time Hyperoxic and Not on Room Air
timeFrame: 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:
measure: Episodes of Hypoxia (SpO2< 88%)
timeFrame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
measure: Episodes of Hyperoxia (SpO2 >96%)
timeFrame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
measure: Ventilator Free Day
timeFrame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
measure: Time to Room Air
timeFrame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
measure: Measured by Daily Sequential Organ Failure Assessment (SOFA)
timeFrame: First 7 days of hospitalization
measure: ICU Length of Stay
timeFrame: From time of emergency department arrival until the date of ICU discharge or death, assessed up to 180 days
measure: Hospital Length of Stay
timeFrame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days
measure: Hospital Discharge Disposition
timeFrame: Date of hospital discharge, assessed up to 180 days
measure: Hospital Mortality
timeFrame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Adit Ginde, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.