An observational study in Air or Gas Embolism, Carbon Monoxide Poisoning and Clostridial Myositis and Myonecrosis (Gas Gangrene), sponsored by U.S. Wound Registry. Status unknown. Per ClinicalTrials.gov, last updated 2018-05-01.
Sponsored by U.S. Wound Registry · Observational
The purpose of the Hyperbaric Oxygen Therapy Registry (HBOTR) is to provide real world patient outcome and side effect information from electronic health records submitted to a specialty specific hyperbaric registry as part of "Stage 2 of Meaningful Use," including data provided to meet PQRS requirements via the registry's QCDR mission.
Goals include understanding the value of HBOT among patients treated for a variety of conditions in relation to the frequency and severity of HBOT side effects. While randomized, controlled trials can establish the efficacy of treatments like HBOT, because they routinely exclude patients with co-morbid conditions common to those patients seen in usual clinical practice, the results of RCTs are usually non-generalizable. Real world data can be used to better understand the effectiveness of HBOT among typical patients, as well as the risks associated with treatment.
The goal of the Hyperbaric Oxygen Therapy Registry (HBOTR) for Wounds is to provide comparative effectiveness data for patients and to understand whether clinical practice guidelines are followed in the use of HBOT.
Hyperbaric Oxygen Therapy (HBOT) is the use of oxygen at greater than one atmosphere (sea level) pressures and is administered by placing the entire patient in a pressurized vessel and having the patient breathe 100% oxygen. The minimum treatment pressure with evidence to support its use among the conditions approved by the Undersea and Hyperbaric Medical society is 2.0 atmospheres absolute (2 ATA) which is an inspired partial pressure of oxygen of approximately 1,520 mmHg. Hyperbaric treatments which provide less than 100% inspired oxygen at the treatment pressure and/or which provide an inspired partial pressure of oxygen less than 760 mmHg are not hyperbaric therapy. Topically applied oxygen is not hyperbaric oxygen therapy. Oxygen is a drug with a well-defined dose response curve as well as acute and chronic drug effects. HBOT also has side effects including oxygen toxicity to many organ systems. The physiological effects of hyperbaric oxygen therapy are well studied. Effectiveness in real world patients is the best current option to understand the role of HBOT in wound healing.
Hospital based outpatient wound centers participating in the US Wound Registry agree to provide data as part of quality initiatives and to meet their Stage 2 Meaningful use criteria. The HBOTR is a subset of the USWR (Chronic Disease Registry) data. All patient data from all participating hyperbaric centers are transmitted to the USWR where data are then used as designated for benchmarking, to satisfy the requirements of PQRS for advanced practitioners, and for data needed by the UHMS to respond to governmental agencies. Data used for effectiveness research are HIPAA de-identified.
44 studies on the registry are indexed under Carbon Monoxide Poisoning; 8 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 104 across 25 observational studies indexed under Carbon Monoxide Poisoning.
Browse Carbon Monoxide Poisoning studies →U.S. Wound Registry is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients seen at participating hospital based outpatient wound and hyperbaric centers where HBOT was administered.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Outcome of problem treated with HBOT
Counts by outcome type
Time frame: 12 Months
Major Amputation in Wagner Grade 3, 4, or 5 Diabetic Foot Ulcers Treated with HBOT
Scored in % of major amputations
Time frame: 12 Months
Preservation of Function with a minor amputation among patients with Wagner Grade 3, 4, or 5 Diabetic Foot Ulcers Treated with HBOT
Scored in % of minor amputations
Time frame: 12 Months
Complications or Side Effects among patients undergoing Treatment with HBOT
Scores in % of: otic barotrauma, other barotrauma, central nervous system oxygen toxicity, confinement anxiety, pneumothorax, sudden respiratory distress, visual acuity changes, low blood sugar, and pulmonary oxygen toxicity.
Time frame: 12 months
Appropriate use of HBOT in patients treated for a Diabetic foot ulcer
Score in % of cases with appropriate use
Time frame: 12 Months
No study locations are listed for this record.
Started Jan 2005 (actual). Primary completion is estimated for Jan 2020, 180 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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U.S. Wound Registry