Traumatic Brain Injury Clinical Trial
— INACHOSOfficial title:
Impact of Intermediate Normal Compared to High Normal Oxygen Levels on Outcomes of Patients Presenting in the Emergency Department With Severe Traumatic Brain Injury (INACHOS): a Pilot Randomized Controlled Trial
Despite almost universal usage of supplemental oxygen therapy in patients presenting in the emergency department with traumatic brain injury (TBI), optimal oxygen levels are unclear. The investigators propose a pilot multi-center randomized controlled trial to test the hypothesis that maintaining intermediate normal as opposed to high normal oxygen levels in patients presenting in the emergency department with TBI is feasible, and to obtain preliminary data on the efficacy of the two approaches to oxygen therapy. The aim is that the investigators produce pilot data, which could inform the design of potential subsequent larger clinical trials.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 2027 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patient =18 years - Glasgow Coma Scale = 8 - Non-penetrating traumatic brain injury - Intubated patient Exclusion Criteria: - Age <18 years - Lack of intention to admit to the intensive care unit - Moribund patient expected to die within 24 hours - Expected need for mechanical ventilation < 24 hours - Time interval from intubation to group allocation more than 60 minutes - Penetrating traumatic brain injury - Pregnancy - Lack of equipoise of the treating clinician - Lack of informed consent |
Country | Name | City | State |
---|---|---|---|
Greece | Evangelismos Hospital | Athens | |
Greece | KAT General Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Evangelismos Hospital |
Greece,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean area-under-curve (AUC) for SpO2 | SpO2 will be recorded each hour for a total duration of 6 hours from intubation. Subsequently, mean area-under-curve (AUC) will be calculated for each group. This will demonstrate the feasibility of the study. | Measurements will be obtained each hour for a total duration of 6 hours from intubation. | |
Primary | Mean area-under-curve (AUC) for FiO2 | FiO2 will be recorded each hour for a total duration of 6 hours from intubation. Subsequently, mean area-under-curve (AUC) will be calculated for each group. This will demonstrate the feasibility of the study. | Measurements will be obtained each hour for a total duration of 6 hours from intubation. | |
Primary | PaO2 | PaO2 will be recorded at least once during 6 hours from intubation. Subsequently, PaO2 values (mmHg) will be calculated for each group. This will demonstrate the feasibility of the study. | Measurements will be obtained at least once during 6 hours from intubation. | |
Secondary | Nosocomial pneumonia | Incidence of nosocomial pneumonia will be recorded for each arm | Within 7 days of subject enrollment | |
Secondary | Acute Respiratory Distress Syndrome (ARDS) | Incidence of ARDS will be recorded for each arm | Within 7 days of subject enrollment | |
Secondary | All-cause mortality | All-cause mortality will be recorded during ICU stay | Within 28 days of subject enrollment | |
Secondary | Extended Glasgow Outcome Score (GOS-E) | A combined outcome of disability and mortality at 6 months using the Extended Glasgow Outcome Score will be assessed | At 6 months following subject enrollment |
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