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Hyperbaric Oxygen Therapy Registry (HBOTR)

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ClinicalTrials.gov Identifier: NCT02483650
Recruitment Status : Enrolling by invitation
First Posted : June 29, 2015
Last Update Posted : May 19, 2016
Sponsor:
Collaborator:
Undersea and Hyperbaric Medical Society (UHMS)
Information provided by (Responsible Party):
U.S. Wound Registry

Brief Summary:

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.


Condition or disease
Air or Gas Embolism Carbon Monoxide Poisoning Clostridial Myositis and Myonecrosis (Gas Gangrene) Crush Injury, Compartment Syndrome & Other Acute Traumatic Ischemias Decompression Sickness Peripheral Arterial Insufficiency and Central Retinal Artery Occlusion Severe Anemia Intracranial Abscess Necrotizing Soft Tissue Infections Osteomyelitis (Refractory) Delayed Radiation Injury (Soft Tissue and Bony Necrosis) Compromised Grafts and Flaps Acute Thermal Burn Injury Idiopathic Sudden Sensorineural Hearing Loss

Detailed Description:

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: The Registry of Hyperbaric Oxygen Therapy Treated Patients
Study Start Date : January 2005
Estimated Primary Completion Date : January 2020





Primary Outcome Measures :
  1. Outcome of problem treated with HBOT [ Time Frame: 12 Months ]
    Counts by outcome type


Secondary Outcome Measures :
  1. Major Amputation in Wagner Grade 3, 4, or 5 Diabetic Foot Ulcers Treated with HBOT [ Time Frame: 12 Months ]
    Scored in % of major amputations

  2. Preservation of Function with a minor amputation among patients with Wagner Grade 3, 4, or 5 Diabetic Foot Ulcers Treated with HBOT [ Time Frame: 12 Months ]
    Scored in % of minor amputations


Other Outcome Measures:
  1. Complications or Side Effects among patients undergoing Treatment with HBOT [ Time Frame: 12 months ]
    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.

  2. Appropriate use of HBOT in patients treated for a Diabetic foot ulcer [ Time Frame: 12 Months ]
    Score in % of cases with appropriate use



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients seen at participating hospital based outpatient wound and hyperbaric centers where HBOT was administered.
Criteria

Inclusion Criteria:

  • Patients receiving Hyperbaric Oxygen Therapy for any UHMS Approved indication

Exclusion Criteria:


Responsible Party: U.S. Wound Registry
ClinicalTrials.gov Identifier: NCT02483650     History of Changes
Other Study ID Numbers: CDR004
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Wounds and Injuries
Ischemia
Embolism
Necrosis
Hearing Loss
Poisoning
Myositis
Burns
Soft Tissue Infections
Osteomyelitis
Compartment Syndromes
Hearing Loss, Sensorineural
Carbon Monoxide Poisoning
Radiation Injuries
Gangrene
Retinal Artery Occlusion
Decompression Sickness
Gas Gangrene
Crush Injuries
Embolism, Air
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases