Patients with severe traumatic brain injuries have high mortality rates and poor long-term outcomes. Hyperbaric oxygen (HBO) therapy has been recognized as a possible way to offset the lack of oxygen available due to an acute brain injury by introducing supplemental HBO before cellular energy failure occurs.
In August 2018, the Hyperbaric Facility at UI Hospitals & Clinics officially began enrolling patients into a multicenter study known as the Hyperbaric Oxygen Brain Injury Treatment Trial (HOBIT). UI Hospitals & Clinics is one of 20 facilities around the nation involved with this study, which investigates what pressure and duration of treatment best suits the needs of this patient population. Currently, eight specific treatment arms are being investigated during the second phase of this trial. Treatment arms are randomly assigned upon successful enrollment in the study.
The Hyperbaric Facility at UI Hospitals & Clinics was considered a favorable candidate for this study based on the ability to care for critically ill patients in the HBO chamber. Dedicated clinicians and the leadership of medical director Merete Ibsen, MD, clinical assistant professor of anesthesia–hyperbaric oxygen therapy, and site investigating physician Nicholas Mohr, MD, MS, clinical associate professor of emergency medicine, anesthesia–critical care medicine, and epidemiology, have been vital to UI Health Care’s participation in this innovative study.
HOBIT study parameters
Patients must meet specific inclusion criteria before enrollment can proceed. This study accepts patients from ages 16–65 with a Glasgow Coma Scale (GCS) of between 3 and 8. Informed consent must be granted by a legally recognized family representative. The initial treatment must be administered within eight hours after arrival to the Emergency Department. Patients requiring a surgical intervention must be able to be treated within 14 hours.
The primary objectives of this study include observing a greater than 50% improvement in neurological outcomes versus control patients from other studies and to select an effective treatment regimen based on the outcomes from each treatment arm.
Primary endpoints include:
- Three- and six-month post-evaluations will be conducted on each study patient.
- The Glascow Outcome Scale – Extended (GOS-E) is used to establish each patient’s condition.
- Patients with a GCS between 3 and 5 are considered favorable if their six-month GOS-E is upper good recovery to upper severe disability.
- Patients with a GCS between 6 and 8 are considered favorable if their six-month GOS-E is upper good recovery to moderate disability.
Secondary endpoints include:
- Analyze level and duration of intracranial pressures (ICP) if >22mmHg in hyperoxia treated patients versus control patients
- Analyze therapeutic intensity level scores for controlling ICP in hyperoxia treated patients versus control patients
- Compare serious adverse events of each treatment arm
This article originally appeared in the 2018 Nursing Annual Report, published in April 2019.